TECHNICAL REVIEW

Endoluminal flexible endoscopic suturing for minimally invasive therapies Nathan E. Conway, MD,1 Lee L. Swanström, MD2 Portland, Oregon, USA

Suturing is a hallmark modality of surgery and is considered critical to many procedures, particularly in the gastroenterology field. The practice of surgery is evolving from open access to laparoscopic and now to endoscopic. Throughout this evolution, the ability to suture has remained the primary metric of complexity for each of these new domains. Intestinal tract closure has been particularly challenging for complex endoscopic surgeries during which inadvertent or intentional perforation of a normal hollow viscus commonly occurs. The American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Working Group at the 2005 Natural Orifice Surgery Consortium for Assessment and Research meeting reported the consensus that successful closure of intentional lumen defects is an absolute necessity for natural orifice transluminal endoscopic surgery (NOTES) to progress and eventually replace other traditional surgical approaches.1 Specifically, it can be said that endoscopic suturing may be the facilitating modality of future lessinvasive approaches and certainly is necessary to handle a wide range of current clinical problems when standard technologies such as clips and staplers fail. The objective of this review is to identify the various means by which the challenge of endoscopic suturing has been addressed to date and to survey the clinical problems currently managed by the available technologies and techniques. Abbreviations: MeSH, medical subject heading; NOTES, natural orifice transluminal endoscopic surgery; SAGES, Society of American Gastrointestinal and Endoscopic Surgeons. DISCLOSURE: Dr Swanström is a consultant for Apollo Medical. Dr Conway disclosed no financial relationships relevant to this article.

METHODS The MEDLINE database was searched for all articles describing endoscopic suturing. Keyword search terms included “endoscopic suturing” or “endoscopy and suturing techniques.” Additionally, the medical subject headings (MeSHs) of gastrointestinal endoscopes, gastrointestinal endoscopy, digestive system endoscopy, NOTES, and suture techniques were searched. Animal studies were included. The topics that included neurologic, sinus, oral-maxillofacial, and urologic surgery were excluded. Finally, abstracts, editorials, and non-English language articles were excluded. The search results were reviewed, and articles were retrieved that specifically described techniques of endoscopic suturing, endoscopic suturing devices, or therapies involving endoscopic suturing. Of these, we focused on articles that related to suturing, ie, placement of suture across target tissues and intraluminal “tying” or “cinching” of the suture, as this is considered to be the specific task that endoscopy must accomplish to overcome the barrier of secure full-thickness closure. Those articles that relate to clipping, stapling, or percutaneous knot tying were therefore excluded. For articles from the same institution where it was perceived that additive series were presented, only the latest and/or largest series were included. Additional articles were identified by a manual review of the reference sections of the initially retrieved articles. All articles were then categorized based on device type, the clinical problem addressed, the study model (eg, human, porcine), and publication year. We also collected information on the number of cases performed for each device. The median number of articles published per year was analyzed and the interquartile range (Q3-Q1) was determined.

RESULTS Use your mobile device to scan this QR code and watch the author interview. Download a free QR code scanner by searching ‘QR Scanner’ in your mobile device’s app store. Copyright ª 2015 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2014.09.013

A total of 1350 articles were identified through keyword search, and an additional 529 were obtained from the MeSH search. These were reviewed individually applying our exclusion criteria, and eventually, 124 relevant articles were determined. The second-line medical literature review yielded an additional 16 articles for a final count of 140 (Fig. 1).

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Endoluminal flexible endoscopic suturing for minimally invasive therapies

The proportional characteristics that each device type contributes to the published articles per year are presented in Figure 2. Articles that described multiple devices were counted as contributing to that particular year for each device studied. Each device was catalogued into the following categories: multitasking platform, dedicated suturing device, and through-the-scope catheter-based devices (eg, T-tags, ENDOLOOPS [Ethicon, Somerville, NJ]). The largest contributor was the category of dedicated suturing devices with 83 articles, followed by through-the-scope catheter-based devices with 49 articles and multitasking platforms with 10 articles.

DISCUSSION

There were 4 randomized, controlled trials: 1 comparing transoral outlet reduction with a sham control for weight regain after Roux-en-Y gastric bypass,2 1 comparing surgical with endoscopic closure of 4-cm colotomies in nonsurvival pigs,3 and the other 2 compared endoscopic suturing with other closure methods of iatrogenic esophageal perforations in survival pigs.4,5 There were 3 prospective case series, all of which reported on endoscopic suturing as a treatment modality for humans with GERD.6-8 The remainder and majority of the article types were retrospective case series and case reports. Table 1 (available online at www.giejournal.org) lists the articles by year. These papers represented a total number of more than 3045 procedures. Of these, 79 reported studies on animals (1 baboon, 7 canine, 72 porcine), 64 reported studies in humans, and 25 reported studies on explanted tissues or organs. Table 2 (available online at www. giejournal.org) shows the number of articles reporting on each type of model. Although a few early reports exist, consistent annual publications on endoscopic suturing techniques began in 1999, with a sharp increase in 2004. Of historical note, the first published report was by Swain and Mills9 in 1986 describing an endoscopic sewing machine tested in human cadavers and survival canine models. The median annual number of publications since 1999, when consistent annual publications began, is 11.0 articles per year. For this same time period, the interquartile range was 12 (Q1 Z 3, Q3 Z 15), with 2011 as a low outlier.

Flexible endoscopy has been in common use for more than 50 years, initially as a purely diagnostic tool but more recently as an important interventional therapy modality.10 As a therapeutic instrument, endoscopy is truly the “queen” of minimally invasive interventions, being far less morbid than surgery and without the radiation exposure and heavy infrastructure requirements of interventional radiologic treatments. In indications where it is applicable, flexible endoscopic procedures have rapidly supplanted even laparoscopic surgeries to the point where once-common operations such as common bile duct explorations, GI bleeding control, treatment of GI tract strictures, and pancreatic pseudocyst drainage are rarely experienced by modern surgical trainees.11,12 This is due, of course, to the patient-friendly profile of almost all endoscopic interventions, most of which require minimal hospitalization, frequently no general anesthesia, are relatively pain free, and allow a rapid, almost instantaneous, return to normal activity. It would be a tremendous boon to society, in a humanitarian and monetary sense, if more surgical operations could be converted to flexible endoscopic interventions. This desirability led to widespread experimentation with “flexible endoscopic surgery” starting in 200413 and eventual limited human application as well.14-18 This NOTES movement generated tremendous interest on the part of clinicians (both surgeons and medical endoscopists), industry, and, to some extent, patients.19,20 There are 2 constraints to the further evolution of surgical interventions based on flexible endoscopy. One is the inherent issue imposed by the predicate flexible endoscope, a design that was optimized for rapid endoluminal examinations of the GI tract and not complex surgical interventions. The other, somewhat related issue, is the ability to securely close enterotomies (intentional or otherwise). In a Delphi process conducted in July 2005 at the international NOTES conference in New York City, the latter issue was assigned priority 1 as the most critical barrier to a NOTES “revolution.”1 There are, of course, multiple closure methods for endoscopic procedures: mucosal clips, glues, and even

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Figure 1. Medical literature review process for articles on endoscopic suturing.

Endoluminal flexible endoscopic suturing for minimally invasive therapies

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Figure 2. The proportion of each type of endoscopic suturing device per year reported.

prototype staplers. For this review, we chose to focus on technologies that approximate open or laparoscopic suturing. In the realm of surgery, suturing has traditionally been the hallmark identifier of surgical skill, mainly because of the critical nature of the functions for which suturing has traditionally been used (eg, hemostasis, closure, anastomosis), but also as a metric of eye/hand coordination. Suturing on inanimate models and knot tying are likely some of the first encounters that medical students and interns have with surgery. This early introduction creates a lasting impression that suturing and knot tying are the “most critical elements of any operation.” This emphasis on suturing has carried through to most specialties in surgery (despite the fact that many specialties seldom suture per se, as staplers, energy devices, clips, and other devices have replaced the actual need for needle and thread in many cases) and even into laparoscopic surgery. The suturing task of the high-stakes Fundamentals of Laparoscopic Surgery exam is one of the 5 tasks of the manual skills examination and, in fact, is the most discriminatory for complex skills mastery.21,22 Since the Natural Orifice Surgery Consortium for Assessment and Research group first published its guidelines for future developments for NOTES technologies, there have been several endoscopic suturing devices introduced by industry and a significant number of peer-reviewed reports of these devices being used. In this report, we

review this body of literature to determine the current state-of-the-art for endoluminal suturing technologies and their applications. A total of 140 articles were identified covering a variety of technologies and approaches. The cumulative picture painted by this summary is of an energetic exploration of possibilities and an overall evolution of endoscopic technologies. The solutions have ranged from simple adaptations of existing devices such as a needle catheter–delivered T-tag with suture (Tissue Apposition System Ethicon, Blue Ash, Ohio) to more sophisticated miniaturized suturing machines fitted to the tip of an endoscope (Overstitch, Apollo Endosurgery, Austin, Tex). Perhaps the ultimate method is suturing performed with an endoscopic bimanual operative platform, although, unfortunately, none of these platforms are commercially available. In this report, the majority of publications report use of suturing machine technology (Table 1, available online at www.giejournal.org). The early experience of the endoscopic suturing has been captured by this review, with many of procedures having been performed by leaders in the field of therapeutic flexible endoscopy, innovators, and early adopters. As adoption of these techniques expands throughout the community of endoscopists, patient safety must remain of paramount importance. Training for advanced therapeutic maneuvers like those described in this review should follow the same guidelines published by the ASGE23 and SAGES.24

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The weaknesses of this review are the inhomogeneous nature of the models described and the paucity of level 1 randomized, prospective, comparative trials in the evaluation. Many articles represented small observational series, and conclusions regarding superiority should be made cautiously. The authors believed that, in consideration of the novelty of the concept and its potentially “disruptive” impact on surgical care, it was worth assessing at this time. We were impressed to find 140 articles published describing more than 3000 procedures. The rapid accumulation of experience and the broad spectrum of cases described may indicate a paradigm shift as large as laparoscopic surgery, the introduction of which has altered the perceptions of surgery, saved countless deaths and morbidities, and resulted in the cumulative savings of billions of health care dollars worldwide.

CONCLUSION We present a comprehensive medical literature review of the current status of endoscopic suturing devices along with the procedures for which they would be used. A surprising number and spectrum of cases were found despite the novelty of the approach (140 articles with a total of 3045 procedures). Although the overall quality of the articles was not high and certainly not enough to compare endoscopic with laparoscopic or open suturing, it would seem to confirm the feasibility and safety of this potentially paradigm-shifting approach. REFERENCES 1. Rattner D, Kalloo A, Singh VK, et al. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. Surg Endosc 2006;20:329-33. 2. Thompson C, Chand B, Chen Y, et al. Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology 2013;145:129-37. 3. Raju G, Fritscher-Ravens A, Rothstein R, et al. Endoscopic closure of colon perforation compared to surgery in a porcine model: a randomized controlled trial (with videos). Gastrointest Endosc 2008;68: 324-32. 4. Fritscher-Ravens A, Hampe J, Grange P, et al. Clip closure versus endoscopic suturing versus thoracoscopic repair of an iatrogenic esophageal perforation: a randomized, comparative, longterm survival study in a porcine model (with videos). Gastrointest Endosc 2010;72:1020-6. 5. Fritscher-Ravens A, Cuming T, Eisenberger C, et al. Randomized comparative long-term survival study of endoscopic and thoracoscopic esophageal wall repair after NOTES mediastinoscopy in healthy and compromised animals. Endoscopy 2010;42:468-74. 6. Abou-Rebyeh H, Hoepffner N, Rösch T, et al. Long-term failure of endoscopic suturing in the treatment of gastroesophageal reflux: a prospective follow-up study. Endoscopy 2005;37:213-6. 7. Arts J, Lerut T, Rutgeerts P, et al. A one-year follow-up study of endoluminal gastroplication (EndoCinch) in GERD patients refractory to proton pump inhibitor therapy. Dig Dis Sci 2005;50:351-6.

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Swanström & Conway 51. Hu B, Chung S, Sun L, et al. Transoral obesity surgery: endoluminal gastroplasty with an endoscopic suture device. Endoscopy 2005;37: 411-4. 52. Ikeda K, Fritscher-Ravens A, Mosse A, et al. Endoscopic full-thickness resection with sutured closure in a porcine model. Gastrointest Endosc 2005;62:122-9. 53. Jagannath S, Kantsevoy S, Vaughn C. Peroral transgastric endoscopic ligation of fallopian tubes with long-term survival in a porcine model. Gastrointest Endosc 2005;61:449-53. 54. Kantsevoy S, Jagannath S, Niiyama H, et al. Endoscopic gastrojejunostomy with survival in a porcine model. Gastrointest Endosc 2005;62: 287-92. 55. Kleemann M, Langner C, Muldner A, et al. Depth of endoscopically placed sutures. Surg Endosc 2005;19:1602-5. 56. Park P, Bergstrom M, Ikeda K, et al. Experimental studies of transgastric gallbladder surgery: cholecystectomy and cholecystogastric anastomosis. Gastrointest Endosc 2005;61:601-6. 57. Schiefke I, Zabel-Langhennig A, Neumann S, et al. Long term failure of endoscopic gastroplication (EndoCinch). Gut 2005;54:752-8. 58. Schiefke I, Zabel-Langhennig A, Neumann S, et al. Use of an endoscopic suturing device (the “ESD”) to treat patients with gastroesophageal reflux disease, after unsuccessful EndoCinch endoluminal gastroplication: another failure. Endoscopy 2005;37: 700-5. 59. Schilling D, Kiesslich R, Galle P, et al. Endoluminal therapy of GERD with a new endoscopic suturing device. Gastrointest Endosc 2005;62:37-43. 60. Wenzel G, Kuhlbusch R, Heise J, et al. Relief of reflux symptoms after endoscopic gastroplication may be associated with reduced esophageal acid sensitivity: a pilot study. Endoscopy 2005;37: 236-9. 61. Bergstrom M, Ikeda K, Swain P, et al. Transgastric anastomosis by using flexible endoscopy in a porcine model (with video). Gastrointest Endosc 2006;63:307-12. 62. Cadiere G, Rajan A, Rqibate M, et al. Endoluminal fundoplication (ELF) – evolution of EsophyXTM, a new surgical device for transoral surgery. Minim Invasive Ther 2006;15:348-55. 63. Celestino C, Harz C, Decaestecker J, et al. Endoscopic treatment of an iatrogenic perforation of the colon by using endoloops. Gastrointest Endosc 2006;64:653-4. 64. Chiu P, Hu B, Lau J, et al. Endoscopic plication of massively bleeding peptic ulcer by using the Eagle Claw VII device: a feasibility study in a porcine model. Gastrointest Endosc 2006;63:681-5. 65. Fritscher-Ravens A, Mosse A, Ikeda K, et al. Endoscopic transgastric lymphadenectomy by using EUS for selection and guidance. Gastrointest Endosc 2006;63:302-6. 66. Hausmann U, Feussner H, Ahrens P, et al. Endoluminal endosurgery: rivet application in flexible endoscopy. Gastrointest Endosc 2006;64: 101-3. 67. Ikeda K, Mosse A, Park P, et al. Endoscopic full-thickness resection: circumferential cutting method. Gastrointest Endosc 2006;64:82-9. 68. Kantsevoy S, Hu B, Jagannath S, et al. Transgastric endoscopic splenectomy. Surg Endosc 2006;20:522-5. 69. Liu J, Carr-Locke D, Osterman M, et al. Endoscopic treatment for atypical manifestations of gastroesophageal reflux disease. Am J Gastroenterol 2006;101:440-5. 70. Liu J, Di Sena V, Ookubo R, et al. Endoscopic treatment of gastroesophageal reflux disease: effect of gender on clinical outcome. Scand J Gastroenterol 2006;41:144-8. 71. Pai R, Fong D, Bundga M, et al. Transcolonic endoscopic cholecystectomy: a NOTES survival study in a porcine model (with video). Gastrointest Endosc 2006;64:428-34. 72. Pham B, Raju G, Ahmed I, et al. Immediate endoscopic closure of colon perforation by using a prototype endoscopic suturing device: feasibility and outcome in a porcine model (with video). Gastrointest Endosc 2006;64:113-9.

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Conway & Swanström 73. Rothstein R, Filipi C, Caca K, et al. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: a randomized, sham-controlled trial. Gastroenterology 2006;131: 704-12. 74. Thompson C, Slattery J, Bundga M, et al. Peroral endoscopic reduction of dilated gastrojejunal anastomosis after Roux-en-Y gastric bypass: a possible new option for patients with weight regain. Surg Endosc 2006;20:1744-8. 75. Fong D, Pai R, Thompson C. Transcolonic endoscopic abdominal exploration: a NOTES survival study in a porcine model. Gastrointest Endosc 2007;65:312-8. 76. Fong D, Ryou M, Pai R, et al. Transcolonic ventral wall hernia mesh fixation in a porcine model. Endoscopy 2007;39:865-9. 77. Fritscher-Ravens A, Patel K, Ghanbari A, et al. Natural orifice transluminal endoscopic surgery (NOTES) in the mediastinum: long term survival animal experiments in transesophageal access, including minor surgical procedures. Endoscopy 2007;39:870-5. 78. Hu B, Kalloo A, Chung S, et al. Peroral transgastric endoscopic primary repair of a ventral hernia in a porcine model. Endoscopy 2007;39: 390-3. 79. Kantsevoy S, Hu B, Jagannath S, et al. Technical feasibility of endoscopic gastric reduction: a pilot study in a porcine model. Gastrointest Endosc 2007;65:510-3. 80. Liu J, Glickman J, Li X, et al. Smooth muscle remodeling of the gastroesophageal junction after endoluminal gastroplication. Gastrointest Endosc 2007;65:1023-7. 81. Mellinger J, MacFadyen B, Kozarek R, et al. Initial experience with a novel endoscopic device allowing intragastric manipulation and plication. Surg Endosc 2007;21:1002-5. 82. Park P, Bergstrom M, Ikeda K, et al. Endoscopic pyloroplasty with fullthickness transgastric and transduodenal myotomy with sutured closure. Gastrointest Endosc 2007;66:116-20. 83. Pleskow D, Rothstein R, Kozarek R, et al. Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results. Surg Endosc 2007;21:439-44. 84. Raju G, Shibukawa G, Ahmed I, et al. Endoluminal suturing may overcome the limitations of clip closure of a gaping wide colon perforation (with videos). Gastrointest Endosc 2007;65:906-11. 85. Ryou M, Pai R, Sauer J, et al. Evaluating an optimal gastric closure method for transgastric surgery. Surg Endosc 2007;21:677-80. 86. Schwartz M, Wellink H, Gooszen H, et al. Endoscopic gastroplication for the treatment of gastro-oesophageal reflux disease: a randomised, sham-controlled trial. Gut 2007;56:20-8. 87. Sumiyama K, Gostout C, Rajan E, et al. Endoscopic full-thickness closure of large gastric perforations by use of tissue anchors. Gastrointest Endosc 2007;65:134-9. 88. Bergstrom M, Swain P, Park P. Early clinical experience with a new flexible endoscopic suturing method for natural orifice transluminal endoscopic surgery and intraluminal endosurgery (with videos). Gastrointest Endosc 2008;67:528-33. 89. Cadiere G, Rajan A, Germay O, et al. Endoluminal fundoplication by a transoral device for the treatment of GERD: a feasibility study. Surg Endosc 2008;22:333-42. 90. Chiu P, Lau J, Ng E, et al. Closure of a gastrotomy after transgastric tubal ligation by using the Eagle Claw VII: a survival experiment in a porcine model (with video). Gastrointest Endosc 2008;68:554-9. 91. Dray X, Gabrielson K, Buscaglia J, et al. Air and fluid leak tests after NOTES procedures: a pilot study in a live porcine model (with videos). Gastrointest Endosc 2008;68:513-9. 92. Fogel R, Fogel J, Bonilla Y, et al. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc 2008;68:51-8. 93. Herron D, Birkett D, Thompson C, et al. Gastric bypass pouch and stoma reduction using a transoral endoscopic anchor placement system: a feasibility study. Surg Endosc 2008;22:1093-9.

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Endoluminal flexible endoscopic suturing for minimally invasive therapies 94. McGee M, Marks J, Onders R, et al. Complete endoscopic closure of gastrotomy after natural orifice translumenal endoscopic surgery using the NDO plicator. Surg Endosc 2008;22:214-20. 95. Overcash W. Natural orifice surgery (NOS) using StomaphyXTM for repair of gastric leaks after bariatric revisions. Obes Surg 2008;18: 882-5. 96. Renteln D, Schiefke I, Fuchs K, et al. Endoscopic full-thickness plication for the treatment of GERD by application of multiple Plicator implants: a multicenter study (with video). Gastrointest Endosc 2008;68: 833-44. 97. Renteln D, Brey U, Riecken B, et al. Endoscopic full thickness plication (Plicator) with two serially placed implants improves esophagitis and reduces PPI use and esophageal acid exposure. Endoscopy 2008;40:173-8. 98. Renteln D, Riecken B, Walz B, et al. Endoscopic GIST resection using FlushKnife ESD and subsequent perforation closure by means of endoscopic full thickness suturing. Endoscopy 2008; 40:E224-5. 99. Renteln D, Kaehler G, Eickhoff A, et al. Gastric full thickness suturing following NOTES procedures for closure of the access site to the peritoneal cavity. Endoscopy 2008;40:E99-100. 100. Renteln D, Schmidt A, Riecken B, et al. Gastric full-thickness suturing during EMR and for treatment of gastric-wall defects (with video). Gastrointest Endosc 2008;67:738-44. 101. Ryou M, Fong D, Pai R, et al. Evaluation of a novel access and closure device for NOTES applications: a transcolonic survival study in the porcine model (with video). Gastrointest Endosc 2008;67: 964-9. 102. Sporn E, Bachman S, Miedema B, et al. Endoscopic colotomy closure for natural orifice transluminal endoscopic surgery using a T-fastener prototype in comparison to conventional laparoscopic suture closure. Gastrointest Endosc 2008;68:724-30. 103. Voermans R, Worm A, Henegouwen M, et al. In vitro comparison and evaluation of seven gastric closure modalities for natural orifice transluminal endoscopic surgery (NOTES). Endoscopy 2008;40: 595-601. 104. Austin R, Mosse C, Swain P. A novel use of T-tag sutures for the safe creation and closure of the NOTES gastrotomy using a hybrid technique. Surg Endosc 2009;23:2827-30. 105. Fritscher-Ravens A, Cuming T, Jacobsen B, et al. Feasibility and safety of endoscopic fullthickness esophageal wall resection and defect closure: a prospective long-term survival animal study. Gastrointest Endosc 2009;69:1314-20. 106. Hookey L, Khokhotva V, Bielawska B, et al. The Queen’s closure: a novel technique for closure of endoscopic gastrotomy for natural orifice transluminal endoscopic surgery. Endoscopy 2009;41:149-53. 107. Hookey L, Bielawska B, Samis A. A reliable and safe gastrotomy closure technique assessed in a porcine survival model pilot study: success of the Queen’s closure. Endoscopy 2009;41:493-7. 108. Moran E, Gostout C, Bingener J. Preliminary performance of a flexible cap and catheter-based endoscopic suturing system. Gastrointest Endosc 2009;69:1375-83. 109. Mullady D, Lautz D, Thompson C. Treatment of weight regain after gastric bypass surgery when using a new endoscopic platform: initial experience and early outcomes (with video). Gastrointest Endosc 2009;70:440-4. 110. Raju G, Malhotra A, Ahmed I. Colonoscopic full-thickness resection of the colon in a porcine model as a prelude to endoscopic surgery of difficult colon polyps: a novel technique (with videos). Gastrointest Endosc 2009;70(1):159-65. 111. Renteln D, Eickhoff A, Kaehler G, et al. Endoscopic closure of the natural orifice transluminal endoscopic surgery (NOTES) access site to the peritoneal cavity by means of transmural resorbable sutures: an animal survival study. Endoscopy 2009;41:154-9. 112. Renteln D, Schiefke I, Fuchs K, et al. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease using

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113.

114.

115.

116.

117.

118.

119.

120.

121.

122.

123.

124.

125.

126.

127.

128.

129.

130.

131.

multiple Plicator implants: 12-month multicenter study results. Surg Endosc 2009;23:1866-75. Ryou M, Mullady D, Lautz D, et al. Pilot study evaluating technical feasibility and early outcomes of second-generation endosurgical platform for treatment of weight regain after gastric bypass surgery. Surg Obes Relat Dis 2009;5:450-4. Thompson C, Ryou M, Soper N, et al. Evaluation of a manually driven, multitasking platform for complex endoluminal and natural orifice transluminal endoscopic surgery applications (with video). Gastrointest Endosc 2009;70:121-5. Trunzo J, Cavazzola L, Elmunzer B, et al. Facilitating gastrotomy closure during natural orifice transluminal endoscopic surgery using tissue anchors. Endoscopy 2009;41:487-92. Borao F, Gorcey S, Capuano A. Prospective single-site case series utilizing an endolumenal tissue anchoring system for revision of post-RYGB stomal and pouch dilatation. Surg Endosc 2010;24: 2308-13. Brethauer S, Chand B, Schauer P, et al. Transoral gastric volume reduction for weight management: technique and feasibility in 18 patients. Surg Obes Relat Dis 2010;6:689-94. Dray X, Krishnamurty D, Donatelli G, et al. Gastric wall healing after NOTES procedures: closure with endoscopic clips provides superior histological outcome compared with threaded tags closure. Gastrointest Endosc 2010;72:343-50. Elmunzer B, Waljee A, Taylor J, et al. Endoscopic full-thickness resection of gastric lesions using a novel grasp-and-snare technique: evaluation in a porcine survival model. Surg Endosc 2010;24:1573-80. Fernandez-Esparrach G, Lautz D, Thompson C. Peroral endoscopic anastomotic reduction improves intractable dumping syndrome in Roux-en-Y gastric bypass patients. Surg Obes Relat Dis 2010;6: 36-40. Fernandez-Esparrach G, Lautz D, Thompson C. Endoscopic repair of gastrogastric fistula after Roux-en-Y gastric bypass: a less-invasive approach. Surg Obes Relat Dis 2010;6:282-9. Hampe J, Schniewind B, Both M, et al. Use of a NOTES closure device for full-thickness suturing of a postoperative anastomotic esophageal leakage. Endoscopy 2010;42:595-8. Horgan S, Jacobsen G, Weiss D, et al. Incisionless revision of postRoux-en-Y bypass stomal and pouch dilation: multicenter registry results. Surg Obes Relat Dis 2010;6:290-5. Mathews J, Chin M, Fernandez-Esparrach G, et al. Early healing of transcolonic and transgastric natural orifice transluminal endoscopic surgery access sites. J Am Coll Surg 2010;210:480-90. Mikami D, Needleman B, Narula V, et al. Natural orifice surgery: initial US experience utilizing the StomaphyXTM device to reduce gastric pouches after Roux-en-Y gastric bypass. Surg Endosc 2010;24:223-8. Park P, Bergstom M, Rothstein R, et al. Endoscopic sutured closure of a gastric natural orifice transluminal endoscopic surgery access gastrotomy compared with open surgical closure in a porcine model. A randomized, multicenter controlled trial. Endoscopy 2010;42:311-7. Renteln D, Schmidt A, Riecken B, et al. Evaluating outcomes of endoscopic full-thickness plication for gastroesophageal reflux disease (GERD) with impedance monitoring. Surg Endosc 2010;24:1040-8. Renteln D, Schmidt A, Vassiliou M, et al. Endoscopic full-thickness resection and defect closure in the colon. Gastrointest Endosc 2010;71:1267-73. Spaun G, Martinec D, Kennedy T, et al. Endoscopic closure of gastrogastric fistulas by using a tissue apposition system (with videos). Gastrointest Endosc 2010;71:606-11. Vegesna A, Korimilli A, Besetty R, et al. Endoscopic pyloric suturing to facilitate weight loss: a canine model. Gastrointest Endosc 2010;72: 427-31. Armengol-Miro J, Dot J, Abadia M, et al. New endoscopic suturing device for closure of chronic gastrocutaneous fistula in an immunocompromised patient. Endoscopy 2011;43:E403-4.

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Swanström & Conway 132. Calisto J, Kawamura J, Trencheva K, et al. Fixation of intestinal tissue using a novel endoscopic device. Surg Innov 2011;18:44-7. 133. Fritscher-Ravens A, Cuming T, Olagbaiye F, et al. Endoscopic transesophageal vs. thoracoscopic removal of mediastinal lymph nodes: a prospective randomized trial in a long term animal survival model. Endoscopy 2011;43:1090-6. 134. Ishimaru T, Iwanaka T, Kawashima H, et al. A pilot study of laparoscopic gastric pull-up by using the natural orifice translumenal endoscopic surgery technique: a novel procedure for treating long-gap esophageal atresia (type A). J Laparosc Adv Surg Tech 2011;21:851-7. 135. Azadani A, Bergstrom M, Dot J, et al. A new in vivo method for testing closures of gastric NOTES incisions using leak of the closure or gastric yield as endpoints. J Laparoendosc Adv Surg Tech A 2012;22:46-9. 136. Bonin E, Song L, Gostout Z, et al. Closure of a persistent esophagopleural fistula assisted by a novel endoscopic suturing system. Endoscopy 2012;44:E8-9. 137. Brethauer S, Chand B, Schauer P, et al. Transoral gastric volume reduction as intervention for weight management: 12-month follow-up of TRIM trial. Surg Obes Relat Dis 2012;8:296-304. 138. Fuchs K, Breithaupt W. Transgastric small bowel resection with the new multitasking platform EndoSAMURAITM for natural orifice transluminal endoscopic surgery. Surg Endosc 2012;26:2281-7. 139. Ishimaru T, Iwanaka T, Hatanaka A, et al. Translumenal esophageal anastomosis for natural orifice translumenal endoscopic surgery: an ex vivo feasibility study. J Laparoendosc Adv Surg Tech 2012;22: 724-9. 140. Jirapinyo P, Watson R, Thompson C. Use of a novel endoscopic suturing device to treat recalcitrant marginal ulceration (with video). Gastrointest Endosc 2012;76:435-9. 141. Kantsevoy S, Thuluvath P. Successful closure of a chronic refractory gastrocutaneous fistula with a new endoscopic suturing device (with video). Gastrointest Endosc 2012;75:688-90. 142. Rajan E, Gostout C, Bonin E, et al. Endoscopic full-thickness biopsy of the gastric wall with defect closure by using an endoscopic suturing device: survival porcine study. Gastrointest Endosc 2012;76: 1014-9. 143. Rieder E, Dunst C, Martinec D, et al. Endoscopic suture fixation of gastrointestinal stents: proof of biomechanical principles and early clinical experience. Endoscopy 2012;44:1121-6. 144. Suhail A, Marvik R, Halgunset J, et al. Efficacy and safety of transgastric closure in natural orifice transluminal endoscopic surgery using the OTSC system and T-bar sutures: a survival study in a porcine model. Surg Endosc 2012;26:2950-4. 145. Thompson C, Jacobsen G, Schroder G, et al. Stoma size critical to 12month outcomes in endoscopic suturing for gastric bypass repair. Surg Obes Relat Dis 2012;8:282-7. 146. Pauli E, Delaney C, Champagne B, et al. Safety and effectiveness of an endoscopic suturing device in a human colonic treat-and-resect model. Surg Innov 2013;20:594-9. 147. Dayyeh B, Rajan E, Gostout C. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc 2013;78:530-5. 148. Jirapinyo P, Slattery J, Ryan M, et al. Evaluation of an endoscopic suturing device for transoral outlet reduction in patients with weight regain following Roux-en-Y gastric bypass. Endoscopy 2013;45: 532-6. 149. Song T, Seo D, Kim S, et al. Endoscopic gastrojejunostomy with a natural orifice transluminal endoscopic surgery technique. World J Gastroenterol 2013;19:3447-52. 150. Fujii L, Bonin E, Baron T, et al. Utility of an endoscopic suturing system for prevention of covered luminal stent migration in the upper GI tract. Gastrointest Endosc 2013;78:787-93. 151. Mori H, Kobara H, Rafiq K, et al. New flexible endoscopic full-thickness suturing device: a triple-arm-bar suturing system. Endoscopy 2013;45: 649-54.

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Conway & Swanström 152. Song Y, Choi H, Kim K, et al. A simple novel endoscopic successive suture device: a validation study for closure strength and reproducibility. Endoscopy 2013;45:655-60. 153. Chiu P, Phee S, Wang Z, et al. Feasibility of full-thickness gastric resection using master and slave transluminal endoscopic robot and closure by overstitch: a preclinical study. Surg Endosc 2014;28:319-24. 154. Liu L, Chiu P, Teoh A, et al. Endoscopic suturing is superior to endoclips for closure of gastrotomy after natural orifices translumenal endoscopic surgery (NOTES): an ex vivo study. Surg Endosc 2014;28:1342-7. 155. Mori H, Kobara H, Fujihara S, et al. Feasibility of pure EFTR using an innovative new endoscopic suturing device: the Double-arm-bar Suturing System (with video). Surg Endosc 2014;28:683-90.

Endoluminal flexible endoscopic suturing for minimally invasive therapies 156. Moustarah F, Talarico J, Zinc J, et al. NOTES for the management of an intra-abdominal abscess: transcolonic peritonoscopy and abscess drainage in a canine model. Can J Surg 2013;56:159-66.

Received June 24, 2014. Accepted September 3, 2014. Current affiliations: Providence Cancer Center, Providence Portland Medical Center (1), Gastrointestinal and Minimally Invasive Surgery Division, The Oregon Clinic (2), Portland, Oregon, USA. Reprint requests: Lee L. Swanström, MD, 4805 NE Glisan St., Suite 6N60, Portland, OR 97213.

Endoscopedia GIE now has a blog! Keep up with GIE news by following us at www.endoscopedia.com.

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Volume 81, No. 2 : 2015 GASTROINTESTINAL ENDOSCOPY 269

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Swanström & Conway

TABLE 1. List of articles related to GI endoscopic suturing by year Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Swain

1986

Endoscopic sewing machine

Hemorrhagic ulcer, GERD

Human, canine

28

18 suture lines formed in human cadaveric stomachs; 9/10 hemorrhagic ulcers controlled in canine stomachs

NR

Escourrou25

1990

Helicoidal wire

Hemorrhagic ulcer

Human, canine

8

6/6 dogs with multiple 25% of devices hemorrhagic ulcers incorporated into controlled immediately; the gastric wall; no 2/2 humans with device-related immediate control of adverse events in bleeding gastric ulcers humans

Kardirkamanathan26 1996

Endoscopic sewing machine

GERD

Human, canine

32

10/10 full-thickness sutures formed in human cadaveric stomachs; canine: 90% stitch survival at median 6-week follow up; improved LES pressure in 10/10 gastroplasties, 3/3 fundoplications, and 0/1 gastropexies

Canine: 0% mortality, temporary dysphagia in one, resolving without intervention

Kardirkamanathan27 1999

Endoscopic sewing machine

GERD

Porcine

6

6/6 pigs with improved LES pressure, decreased acid exposure

0% mortality; no significant adverse events

Martinez-Serna28

2000

Endoscopic sewing machine

GERD

Baboon

17

Increased LES pressure in linear suture group (n Z 8), nonsignificant increase in circular suture group (n Z 9); increased intraabdominal length in both groups

0% morbidity and mortality

Adler29

2001 EndoCinch (C.R. Bard, Murray Hill, NJ)

Esophagopleural fistula

Human

1

No residual fistula at 2-week follow-up; asymptomatic at 8 mo

NR

Filipi30

2001

Endoscopic suturing system

GERD

Human

64

53/64 required a single 0% mortality; 31% pharyngitis, 14% procedure; improved vomiting, 14% heartburn scores, QOL, abdominal pain, no. of reflux episodes, acid exposure at 6 mo; 16% chest pain, 3% mucosal tear, 6% no difference in LES hypoxia, 3% gastric measurements or bleeding, 2% suture esophagitis grade perforation

Suzuki31

2001

Loop

Intestinal closure

Human

3

2/3 successful closures (duodenotomy required laparoscopyassisted closure)

NR

Awan32

2002

Endoscopic sewing machine

Obesity

Porcine

1

Technically feasible in porcine cadaveric stomach

NR

9

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Chuttani33

2002

NDO Plicator (NDO Surgical Inc, Mansfield, Mass)

GERD

Porcine

36

16 plications successfully placed in 11 pigs; improved gastric retention pressures

0% morbidity and mortality

Fritscher-Ravens34

2002

T-tag

Undefined

Porcine

100

100 sutures successfully placed in various tissues; 19/20 placed in the planned tissue layer; 15/15 hollow organs fixed to stomach

NR

Velanovich35

2002 EndoCinch (C.B. Bard)

GERD

Human

27

78% satisfied at 6-week follow-up; improved satisfaction and symptom scores

NR

Chuttani36

2003

NDO Plicator

GERD

Human

7

6/7 patients were plicated; 1 could not be adequately sedated; 1 underwent laparoscopic fundoplication for persistent symptoms; improved QOL and symptom scores

0% mortality; no significant adverse events

Fritscher-Ravens37

2003

T-tag

GJ anastomosis

Porcine

14

14/14 successful anastomoses

NR

Mahmood38

2003

EndoCinch

GERD

Human

26

Improved symptom, QOL and DeMeester scores

Transient symptoms that resolved spontaneously; 8% hemorrhage; 4% mucosal tear; 0% mortality

Chadalavada39

2004

EndoCinch

GERD

Human

47

66% satisfied; 27% resumed previous medication use

57% pharyngitis, 13% hypoxia, 4% aspiration, 4% nausea, vomiting, 2% bleeding, 2% mucosal tear; 0% mortality

Fritscher-Ravens40

2004

T-tag

GERD

Porcine

22

Posterior gastropexy successful in 18/18 pigs; crural repair in 4/4 pigs; improved LES pressures; correct stitch placement confirmed in 14/18 gastropexy pigs and intact stitch in 3/4 crural repair pigs post mortem

0% mortality; no significant adverse events

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Liu41

2004

EndoCinch

GERD

Human

25

20/25 required a single procedure; improved heartburn and regurgitation symptom scores; 50% off medication; 37% resumed previous medication use

4% bleeding, 4% aspiration pneumonia; 0% mortality

Matsuda42

2004

ENDOLOOP

ESD mucosal closure

Human

1

5-cm post-resection defect closed

0% morbidity and mortality

Pleskow43

2004

Plicator

GERD

Human

64

64/64 required a single 41% pharyngitis, 20% abdominal procedure; 61% had an pain, 17% chest improvement in pain, 17% GI symptoms; 65% disorder, 14% patients able to eructation, 11% discontinue dysphagia, 9% medications; decreased dyspnea, 6% acid exposure; no nausea, 2% change in LES resting pneumothorax, 2% pressure pneumoperitoneum

Schiefke44

2004

EndoCinch

GERD

Human

53

64% “successful”, 74% had a O50% reduction in medication use; improved median heartburn severity score

NR

Schweitzer45

2004

Endoscopic suturing device

Weight regained after RYGB

Human

4

4/4 successful stoma size reduction

No adverse events

Tam46

2004

EndoCinch

GERD

Human

15

Increased mean postprandial basal LES pressure but not fasting pressures, reduced rate of transient LES relaxation, decreased acid exposure, improved symptom scores

27% dysphagia; no major adverse events

Tuebergen47

2004

EndoCinch

GERD

Human

1

Laparoscopic fundoplication performed as a result of an adverse event

Esophageal injury

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Abou-Rebyeh

2005

EndoCinch

GERD

Human

38

33/38 required a single 5% fever, 3% chest pain, 3% vomiting; endoscopic gastric 0% mortality plication; at 1 year, 74% sutures lost, 16% loose, 10% in good position, 39% symptom improvement, 14% heartburn free, reduction in medication use, 66% patients with reduced acid exposure; normal acid exposure in 14% at 1 year

Arts7

2005

EndoCinch

GERD

Human

20

9/20 required a single 5% dysphagia; mild sore throat, mild procedure; 32 epigastric pain plications in 20 common patients; at 1 year, improved symptom scores, 30% asymptomatic, off medications; 1/4 with preoperative esophagitis had healed at 1 year; 30% with normal acid exposure

Chen48

2005

EndoCinch

GERD

Human

85

2/85 underwent Nissen 2% bleeding, 2% hypoxia, 1% due to poor response bronchospasm, 1% to gastroplication; improved heartburn dysphagia requiring an endoscopic and regurgitation intervention; 0% scores; 73% decreased mortality PPi use, 43% with no PPi use; improved acid exposure and residual pressure though no significant change in LES pressure

Hu49

2005

Eagle Claw II

Hemorrhage

Porcine

25

68% plicated successfully; 4/25 penetrated the vessel wall; 2/25 had loose knots

NR

Hu50

2005

Eagle Claw V

Hemorrhage

Porcine

15

73.3% plicated successfully; 4/15 failures: 2 with suture breakage, 1 with thread entanglement, and 1 with cartridge dislodgment

NR

Hu51

2005

Eagle Claw VII

Obesity

Porcine

1

Successful formation of 100-mL gastric pouch; 100% of sutures achieved muscular penetration

NR

6

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Outcomes

Adverse Events

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

52

Ikeda

2005

T-tag

Gastrotomy closure

Porcine

8

20 sutures used to close 8 perforations; 8/8 successful closures; 7/8 suture complexes present at follow-up endoscopy

No bleeding or peritonitis

Jagganath53

2005

ENDOLOOP

Gynecologic

Porcine

6

6/6 fallopian tubes successfully ligated

No adverse events

Kantsevoy54

2005

Eagle Claw

GJ anastomosis

Porcine

2

2/2 successful gastrojejunostomies; survived for planned 2-week duration

NR

Kleemann55

2005

EndoCinch

Esophageal suturing

Human

10

62 sutures placed in 10 cadaveric esophagi. At 0.4 bar (0.6, 0.8 bar), 0% (0%, 1.6%) were placed in the submucosa, 3.2% (0%, 1.6%) in the circular muscularis propria, and 11% (25.8%, 12.9%) in the longitudinal muscularis propria, with 12.9% (6.5%, 17.7%) placed transmurally

NR

Park56

2005

T-tag

Gastrotomy closure

Porcine

16

8/8 successful cholecystectomies, 3/3 successful cholecystogastrotomies

NR

Schiefke57

2005

EndoCinch

GERD

Human

70

56/70 failures based on 83% pharyngeal symptoms and PPi use; pain, 11% bleeding; 17% had sutures in situ; 0% mortality no remaining sutures in 26%; no change in acid exposure or LES pressure

Schiefke58

2005

Endoscopic suturing device

GERD

Human

20

85% transient chest 20/20 procedures pain, abdominal completed; at 6 mo, 5% had sutures in situ; no pain, nausea, 10% bleeding; 0% remaining sutures in mortality 15%; heartburn symptoms improved, but QOL unchanged; no changes in esophagitis, acid exposure, or manometry findings

Schilling59

2005

Endoscopic suturing device

GERD

Human, porcine

28

40 plications in 8 pig 65% transient chest, abdominal pain, stomachs, all sutures within the muscularis 20% bloating, 15% mild dysphagia propria; in humans, 12% sutures in situ at 3 mo; unchanged acid exposure, PPi use, LES pressure

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Wenzel

2005

EndoCinch

GERD

Human

6

6/6 gastroplications completed; improved symptoms, QOL; decreased PPi use; no change in esophagitis, acid exposure, or manometry findings

No adverse events

Bergstrom61

2006

T-tag

GJ anastomosis

Porcine

12

12/12 gastrojejunostomies formed; patent anastomosis at 7-10 days

NR

Cadiere62

2006

Esophyx (EndoGastric Solutions, San Mateo, Calif)

GERD

Canine

19

146 fasteners placed in 19 canines that underwent endoluminal fundoplication; all without bloating, dysphagia or other eating disorders

1 unrelated death

Celestino63

2006

ENDOLOOP

Colotomy closure

Human

1

15-mm iatrogenic perforation closed by ENDOLOOPS; clinically well at 4-month followup

NR

Chiu64

2006

Eagle Claw VII

Hemorrhagic ulcer

Porcine

6

14 plications on 6 pigs with hemorrhagic ulcers; no recurrent bleeding at 1 week; 10/14 plications present at 1 week postmortem examination

17% mild bilious vomiting

Fritscher-Ravens65

2006

T-tag

Lymph node retrieval

Porcine

2

2 defects closed successfully after gastrotomy for lymph node retrieval

NR

Hausmann66

2006

Rivet

Gastrotomy closure

Porcine

1

A single rivet application in gastric mucosa

NR

Ikeda67

2006

T-tag

Gastrotomy Closure, Hemorrhage

Porcine

12

12/12 full-thickness 25-mm defects closed; 8/8 fully healed at 28 days

8% bleeding controlled endoscopically; 0% mortality

Kantsevoy68

2006

ENDOLOOP

Splenic disorders

Porcine

6

6/6 splenic vessels ligated with ENDOLOOPS

NR

60

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Liu69

2006

EndoCinch, endoscopic suturing device

GERD

Human

39

Endoscopic gastroplication performed in 43 patients; 39 with short-term follow-up; heartburn, regurgitation, cough, hoarseness, wheeze, chest pain improved at 6 mo; cough not improved at long-term follow-up

5% bleeding, 3% aspiration pneumonia; 0% mortality

Liu70

2006

EndoCinch, endoscopic suturing device

GERD

Human

95

Endoscopic gastroplication performed in 95 patients; complete response in 32% male, 36% female patients; no response in 20% male, 21% female patients; no sex differences

NR

Pai71

2006

ENDOLOOP

Colotomy closure

Porcine

5

5/5 cystic duct, cystic arteries ligated; 4/5 colotomy closures;

20% peritonitis due to incompletely closed colotomy

Pham72

2006

Eagle Claw

Colotomy closure

Porcine

10

8/10 colon perforations closed without subsequent peritonitis

13% dehiscence

Rothstein73

2006

NDO Plicator

GERD

Human

78

56% achieved O50% reduction in GERD symptoms vs sham group (19%); cessation of PPi use in 50% in treated group and improved acid exposure compared with sham group

50% experienced R1 symptoms; no serious adverse events; no perforations; 0% mortality

Thompson74

2006

EndoCinch

Weight regain after RYGB

Human

8

50% sore throat, 11 reductions 38% nausea, 25% performed in 8 transient abdominal patients; 3 patients pain, 13% underwent a second constipation reduction; average reduction of 68% in pouch size and 10-kg average weight loss in 6 patients; 6/8 patients had weight loss at 4 mo

Fong75

2007

ENDOLOOP, prototype purse-string suture device

Colotomy closure

Porcine

6

6/6 colotomy closures of defects up to 15 mm; closure time was up to 30 min with ENDOLOOPS and clips, 2 min with the suturing device; no ill effects at 14 days

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Fong

2007

T-tag, ENDOLOOP

Hernia

Porcine

5

5/5 meshes transferred and secured; 10/12 sutures confirmed; Colotomy closure successful; 3/3 survival pigs with no ill effects at 14 days

No infectious adverse events

Fritscher-Ravens77

2007

T-tag

Esophagotomy closure

Porcine

9

6/6 2 cm full-thickness esophagotomy closures; well-healed at 6 week follow up

No significant adverse events

Hu78

2007

Eagle Claw

Hernia

Porcine

2

A 3  2-cm ventral hernia closed with 5 or 6 sutures by using an endoscopic suturing device; sutures placed into abdominal wall aponeurosis or muscle

NR

Kantsevoy79

2007

Eagle Claw

Obesity

Porcine

4

4/4 gastric reductions requiring 12-14 stitches in each animal; created pouch was w30 mL; no serosal penetration

NR

Liu80

2007

EndoCinch

GERD

Porcine

7

7/7 endoscopic gastroplications performed with 2 sutures in each pig; persistent smooth muscle cell hypertrophy after removal of mucosal sutures

NR

Mellinger81

2007

USGI Endosurgical Operating System (USGI Medical, San Clemente, Calif)

Gastrotomy closure

Canine, porcine

1

Successful cardia augmentation; plications persisted at 4-week follow-up

NR

Park82

2007

In-scope

Gastrotomy closure

Porcine

10

10/10 pyloroplasties performed; 6/7 survival pigs had uneventful recoveries; suture visible in 4/7 pigs at follow-up

14% vomiting; iatrogenic perforation followed by euthanasia

Pleskow83

2007

Plicator

GERD

Human

29

45% sore throat, 29/29 underwent 41% abdominal gastroplication; at 36 pain, 24% chest mo, 57% remained off PPi therapy, improved pain, 21% transient dysphagia, 7% symptom scores vs dyspnea, 3% baseline off medications but not on mucosal abrasion; no late adverse medications, improved events; 0% QOL mortality

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Raju

2007

T-tag

Colotomy closure

Porcine

4

4/4 closures of 4-cm colotomy incisions; all survived 2 wk; all sutures present at 2 wk

25% clinical peritonitis; 50% histologic peritonitis

Ryou85

2007

LSI prototype suturing device

Gastrotomy closure

Porcine

5

5/5 18-mm gastrotomy incisions closed with suturing device; median air leak pressures of 85 mm Hg, significantly higher than hand-sewn (47 mm Hg), clip closure groups (33 mm Hg)

NR

Schwartz86

2007

EndoCinch

GERD

Human

19

19/20 successful gastroplications; 65% in the active group had O50% reduction in PPi use compared with sham (25%) or control (0%) groups; improved acid exposure, symptoms, and QOL

No major adverse events

Sumiyama87

2007

T-tag

Gastrotomy closure

Porcine

12

12/12 gastrotomies closed, O2 cm defects; all survived 1 wk with no ill effects; all sites closed firmly with anchors intact

13% anchors penetrated adjacent organs (abdominal wall, liver), 8% bleeding

Bergstrom88

2008

T-tag

Multiple

Human

3

Perforated duodenal ulcer closed successfully, healing at 1 wk follow-up; bleeding gastric ulcer successfully ligated; gastrojejunostomy leak required 2 separate attempts

NR

Cadiere89

2008

Esophyx

GERD

Human

17

100% mild 17/17 endoluminal epigastric pain, 65% fundoplications pharyngeal completed with 14/17 irritation, 6% tight valves created, 3/17 moderately tight; transient dystonia all hiatal hernias reduced and remained reduced in 62%

Chiu90

2008

Eagle Claw VII

Gastrotomy closure

Porcine

10

10/10 fallopian tube ligation and 15-mm gastrotomy closures; all pigs survived 2 wk

10% esophageal perforation

Dray91

2008

T-bars

Gastrotomy closure

Porcine

12

12/12 gastrostomies closed; successful air and fluid leak tests; complete healing at 1 wk

NR

84

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Fogel

2008

EndoCinch

Obesity

Human

64

64/64 endoluminal 3% reflux, 2% vomit vertical gastroplasties; 58% reduction in excess body weight at 12 mo; 11/14 sutures intact at follow-up

Herron93

2008

USGI Endosurgical Operating System

Weight regain after RYGB

Porcine

10

Successful decrease in stoma diameter from 30%-50% in ex vivo and live models

NR

McGee94

2008

NDO Plicator

Gastrotomy closure

Porcine

4

3/3 successful in vivo closures; no leak on fluoroscopy; closures remained intact with pressure up to 55 mm Hg

NR

Overcash95

2008

StomaphyX (EndoGastric Solutions, San Mateo, Calif)

Obesity

Human

2

Incomplete gastrojejunostomy leak closure, healed at 6-mo follow-up; vertical sleeve gastrectomy leak closure, healed at 3-mo follow-up

NR

Raju3

2008

Tissue apposition system

Colotomy closure

Porcine

27

37% peritonitis 26/27 successful (26% in surgical endoscopic closure of group, P Z .19), 4-cm colotomies compared with surgical 2.7% sutures placed into adjacent closure. Suture alone viscera used in 12/27; 1 inadvertent placement into adjacent small bowel

Renteln96

2008

Ethicon plicator

GERD

Human

41

44% abdominal 41/41 underwent pain, 20% shoulder gastroplication; at 6 pain, 17% chest mo, 76% improvement pain, 15% in symptoms, 85% with O50% reduction in PPi pharyngolaryngeal pain, 5% use, 38% decreased pneumoperitoneum acid exposure, 25% improved medial LES resting pressure

Renteln97

2008

Ethicon plicator

GERD

Human

37

65% mild 37/37 underwent abdominal pain, gastroplication; at 6 57% retrosternal mo, 68% had O50% pain, 54% sore improvement in throat, 30% symptoms; 83% with O50% reduction in PPi shoulder pain, 24% bloating, 11% use; 36% decreased nausea, 8% acid exposure, 24% moderate/severe normalization of acid exposure; 35/36 sutures abdominal pain, 3% fever; 8% required visualized at 6 mo hospitalization

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Adverse Events

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Renteln98

2008

NDO plicator

Gastrotomy closure

Human

1

Gastric wall perforation closure, size not reported; complete closure confirmed at 72 h

NR

Renteln99

2008

NDO plicator

Gastrotomy closure

Porcine

2

1/2 successful closures of NOTES cholecystectomy gastric perforation; gastric debris and poor visibility precluded proper closure of the first pig

No significant adverse events

Renteln100

2008

NDO plicator

Gastrotomy closure

Human

4

Gastric perforation after EMR closed successfully; fullthickness gastric suture placement followed by mucosectomy in 2 patients; closure of gastrocutaneous fistula

No procedurerelated adverse events

Ryou101

2008

LSI prototype suturing device

Colotomy closure

Porcine

4

4/4 successful colotomy closures, size not reported; no peritonitis

No significant adverse events

Sporn102

2008

Tissue apposition system

Colotomy closure

Porcine

8

8/8 successful colotomy closures; defects sized 2-5 cm; a minimal air leak at a T-tag site

NR

Voermans103

2008

Multiple

Gastrotomy closure

Porcine

77

18-mm gastrotomies closed with 7 different devices; leak pressures: flexible stapler (244 mm Hg), Endostitch (231 mm Hg), resolution clips (202 mm Hg), Eagle Claw VIII (187 mm Hg), T tags (138 mm Hg), purse-string suturing device (102 mm Hg), purse-string T tags (73 mm Hg)

NR

Austin104

2009

T-tag

Gastrotomy closure

Porcine

3

20-mm gastrotomy closure, confirmed by laparoscopy

NR

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Birk

2009

Plicator

GERD

Human

131

131 underwent gastroplication; 3 underwent laparoscopic Nissen without incident; 1 requested plicator removal; 66% had O50% improvement in symptoms

12% pharyngolaryngeal pain, 12% chest pain, upper abdominal pain 10%

Fritscher-Ravens105

2009

T-tag

Esophagotomy Closure

Porcine

12

Full thickness esophageal defects O 2 x 0.5 cm closed; 2/9 had a larger defect than intended; 3/12 experienced technical malfunctions; 0/12 mediastinitis

8% (nZ1) abscess secondary to technical malfunction

Hookey106

2009

PolyLoop (Olympus America, Center Valley, Pa)

Gastrotomy closure

Porcine

5

5/5 16-mm gastric defects closed; mean leak pressure 51.8 mm Hg

NR

Hookey107

2009

PolyLoop

Gastrotomy closure

Porcine

5

5/5 gastric defects closed; no peritonitis in all animals

No significant adverse events

Moran108

2009

Endoscopic suturing device

Gastrotomy closure

Porcine

2

18-mm gastrotomy purse-string closure and edge-to-edge tissue apposition; no leak

NR

Mullady109

2009

USGI Endosurgical Operating System

Weight regain after RYGB

Human

20

17/20 successful reduction of diameter; 65% reduction in diameter; mean weight loss of 8.8 kg at 3 mo

No significant adverse events

Raju110

2009

Tissue apposition system

Colotomy closure

Porcine

20

19/20 successful fullthickness colotomy closures; 2-cm defects; 5% failure due to technical difficulty

5% peritonitis

Renteln111

2009

Ethicon Plicator

Gastrotomy closure

Porcine

10

10/10 successful gastrotomy closures; 8/10 stomachs tolerated greater than 100 mm Hg without leakage

20% gastric mucosal injury, 10% esophageal mucosal laceration

Renteln112

2009

Ethicon Plicator

GERD

Human

41

41/41 successful 44% abdominal gastroplications; at pain, 24% shoulder 1 year, 74% of patients pain, 17% chest had O50% pain improvement in symptoms and 69% were off PPi therapy

8

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Ryou113

2009

USGI Endosurgical Operating System

Weight regain after RYGB

Human

5

5/5 successful stoma reduction; average reduction in diameter 21 mm, pouch length 4.4 cm; average weight loss 7.8 kg at 3 mo

20% nausea and vomiting

Thompson114

2009

Direct drive endoscopic system

Gastrotomy closure

Porcine

3

Completed specified tasks successfully; 2.4and 2.6-cm mucosal resections performed and sutured close

NR

Trunzo115

2009

Tissue apposition system

Gastrotomy closure

Porcine

5

5/5 gastrotomy sites closed with full-thickness sutures; no leak on necropsy; mean burst pressure 41 mm Hg

11% inadvertent sutures placed

Borao116

2010

Incisionless operating platform

Weight regain after RYGB

Human

20

20/21 successful anchors placed; average stoma reduction 53%; mean weight loss 17 lb

5% sore throat

Brethauer117

2010

RESTORe Suturing System (C.R. Bard)

Obesity

Human

18

18/18 plications placed with gastric volume reduction

Nausea, vomiting, abdominal discomfort common

Dray118

2010

T-tag

Gastrotomy closure

Porcine

12

12/12 2-cm gastrotomies closed; no leak at necropsy after 2 wk; 14%-46% dislodged rate at 2 wk

8% inadvertent sutures placed

Elmunzer119

2010

Tissue apposition system

Gastrotomy closure

Porcine

7

7/7 1.5- to 2-cm full-thickness gastric resections performed; 7/7 successfully closed on fluoroscopic exam; 2/7 early failures of closure

14% abscess, 14% peritonitis, 14% death, 29% ulcer

FernandezEsparrach120

2010

EndoCinch

Dumping syndrome

Human

6

6/6 successfully reduced diameter of GJ anastomosis from a mean of 23 mm to 8 mm; 6/6 had resolution of dumping syndrome

17% hematemesis

FernandezEsparrach121

2010

EndoCinch

Gastrogastric fistula

Human

63

71/71 underwent endoscopic repair of gastrogastric fistula by EndoCinch, 8/71 unable to be completed due to angulation

100% nausea or abdominal discomfort, 1% bleeding, 1% esophageal perforation, 1% small-bowel obstruction

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

4

Fritscher-Ravens

2010

T-tag

Esophagotomy closure

Porcine

6

Mediastinitis due to 18/18 2- to 2.5-cm leak after esophagotomies were thoracoscopic closed with 3 closure and due to techniques, reflux into the randomized to mediastinum endoscopic clip during endoscopic closure, endoscopic suturing; 17% suturing, or mortality in thoracoscopic suturing thoracoscopic and endoscopic suturing groups

Fritscher-Ravens5

2010

Tissue apposition system

Esophagotomy closure

Porcine

12

24/24 2- to 2.5-cm esophagotomies were closed with 2 techniques, randomized to endoscopic or thoracoscopic closure

No significant difference in adverse events or death between the 2 arms of the study

Hampe122

2010

T-tag

Esophagotomy closure

Human

1

Successful closure of anastomotic leak 2 wk after esophagojejunostomy

NR

Horgan123

2010

Incisionless operating platform

Weight regain after RYGB

Human

112

112/116 anchors successfully placed; reduction of stoma diameter (50%) and length (44%); 18% excess weight loss

41% pharyngitis, 12% nausea/ vomiting, 11% abdominal pain, !3% esophageal tear

Mathews124

2010

ENDOLOOP, T-tag

Gastrotomy, colostomy closure

Porcine

16

16/16 8- to 10-mm colotomies, 5- to 10-mm gastrotomies successfully closed

63% inadvertent placement of suture

Mikami125

2010

StomaphyX

Weight regain after RYGB

Human

39

39/39 successful stoma 87% sore throat, reductions; average 77% epigastric pain weight loss at 6 mo, 8.7 kg

Park126

2010

Tissue apposition system

Gastrotomy closure

Porcine

16

32/32 20-mm gastrotomies closed with either endoscopic suture or open closure; secure at necropsy

19% mortality (gastric dilation, rectal prolapse, abdominal dehiscence), 13% peritonitis

Renteln127

2010

Ethicon Plicator

GERD

Human

12

12/12 gastroplications performed; 1 technical issue without adverse event

No post-procedure adverse events

Renteln128

2010

Endoscopic loop

Colotomy closure

Porcine

8

Full-thickness colon resections, 1.2- to 2.2-cm defects; mean burst pressure, 77 mm Hg; all sutures intact at 6 mo; decreased acid exposure

NR

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Outcomes

Adverse Events

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Spaun129

2010

Tissue apposition system

Gastrogastric fistula

Human

5

5/5 gastrogastric fistulae closed; 6-mo gastroscopy 0/6 remained closed

NR

Vegesna130

2010

EndoCinch

Obesity

Canine

7

7/7 dogs underwent pyloric suturing vs sham and control dogs; 48% decreased food consumption, 13% weight loss

NR

Armengol-Miro131

2011

Overstitch

GC fistula

Human

1

Successful closure of persistent 5-mm gastrocutaneous fistula

NR

Calisto132

2011

Brace bar

Volvulus

Porcine

135

BraceBar fixation strength equivalent to suture, superior to ProTack (Covidien, Mansfield, Mass)

NR

Fritscher-Ravens133

2011

T-tag

Lymph node retrieval

Porcine

12

Successful endoscopic closure of esophagotomy after lymph node retrieval; no mediastinal abscess

NR

Ishimaru134

2011

Brace bar

Esophageal anastomosis

Porcine

9

20% (n Z 1) 3/8 end-to-side esophagoesophageal hemorrhagic death anastomosis completed; 3 failed due to anatomic difficulties; of the 5 remaining pigs with a different technique, 3 were successful

Azadani135

2012

T-tag

Gastrotomy closure

Porcine

5

5/5 20-mm gastrotomies closed by endoscopic suturing compared with 4 other closure techniques; mean yield pressure, 90 mm Hg with 1 leak at 56 mm Hg

NR

Bonin136

2012

Overstitch

Esophagopleural fistula

Human

2

10-mm esophagopleural fistula closed with overstitch, 5-mm leak at 4-mo esophagram with complete closure

NR

Brethauer137

2012

RESTORe Suturing System

Obesity

Human

18

18/18 gastroplications performed; excess weight loss at 12 mo 28%; at 12 mo, 5/18 plications intact

6% moderate diarrhea; mild abdominal pain, abdominal distention, nausea, and diarrhea were common and temporary

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Fuchs

2012

EndoSamurai (Olympus, Tokyo, Japan)

Intestinal anastomosis

Porcine

7

7/7 small-bowel anastomoses completed and compared with stapler and hand sewn; leak pressure, 14 mm Hg, equivalent to that with hand sewn

NR

Ishimaru139

2012

BraceBar

Esophageal anastomosis

Porcine

7

7/8 successful 1 device failure and esophagoesophageal 1 leak from needle anastomoses, 1 device holes failure; median leak pressure in 6/7 was 122 mm Hg

Jirapinyo140

2012

Overstitch

Marginal ulcer

Human

3

3/3 marginal ulcers sutured successfully; complete resolution at 6 wk in 2/3, the other had unrelated intussusception

33% bleeding, controlled with epinephrine

Kantsevoy141

2012

Overstitch

GC fistula

Human

1

Successful closure of GC fistula, remained closed at 1-mo follow-up

NR

Rajan142

2012

Overstitch

Gastrotomy closure

Porcine

12

12/12 full-thickness gastric biopsies closed; mean defect size 11 mm; retained sutures in 10/12 and complete healing in all at 2 wk

42% adhesions

Rieder143

2012

Overstitch

Stent migration

Porcine, human

17

20% stent migration 12/12 endoscopic attributed to suture stent fixations performed successfully superficially placed suture on porcine explants; increased force to displace sutured stent compared with stent with clip fixation or stent without fixation; 5/5 stents fixated in patients; 3/4 stents in place at follow-up endoscopy

Suhail144

2012

T-bar

Gastrotomy closure

Porcine

7

7/7 1-cm gastrotomies closed successfully; no leak of methylene blue

NR

Thompson145

2012

USGI Endosurgical Operating System

Weight regain after RYGB

Human

112

112/116 patients had successful anchors placed; reduction of 50% in stoma diameter and 44% in pouch length; mean weight loss at 12 mo, 5.9 kg

NR

138

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

146

Pauli

2013

Overstitch

Colotomy closure

Human

4

4/4 patients underwent endoscopic suturing before surgical colectomy; all sutures placed in subserosal layer consistently; 1 suture unable to be placed due to device failure

NR

Thompson2

2013

EndoCinch

Weight regain after RYGB

Human

48

2% gastric mucosal 48/50 underwent tear proposed procedure; GJ reduced to %10 mm in 90% of patients; significant weight loss at 6 mo compared with sham control

Dayyeh147

2013

Overstitch

Obesity

Human

4

4/4 successful endoscopic sleeve gastroplasties; 3- mo follow-up endoscopy showed 2/2 intact sleeve gastroplasties, a small portion of the fundus was open in 1

Jirapinyo148

2013

Overstitch

Weight regain after RYGB

Human

25

25/25 underwent 16% bleeding, 16% endoscopic gastric nausea or vomiting, 4% esophageal pouch reduction; 25/25 had reduction of GJ abrasion, 4% GJ to %12 mm, mean of stenosis 6 mm

Song149

2013

T-tag

GJ anastomosis

Porcine

10

8/10 successful transgastric GJ anastomoses performed; obstruction in 1 and rupture in another were the 2 failures

Fujii150

2013

Overstitch

Stent migration

Human

18

16/18 required a single- No adverse events suture fixation directly related to procedure; stent suturing procedure migration in 33% at a median 21 days

Mori151

2013

Triple-arm bar suturing device

Gastrotomy closure

Porcine

20

20/20 50-mm gastrotomies closed; superior maximum pulling force durability compared with over-the-scope clips and equivalent to hand-sewn techniques

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75% abdominal pain and nausea, 25% acid reflux

10% adhesion

NR

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TABLE 1. Continued Author last name, ref.

Year

Device

Clinical Problem

Model

Procedures

Outcomes

Adverse Events

Song152

2013

T-tag

Gastrotomy closure

Porcine

10

10/10 18-mm gastrotomies closed; superior leak pressures to clip closure but inferior to hand-sewn techniques

NR

Chiu153

2014

Overstitch

Gastrotomy closure

Porcine

2

2/2 5-cm gastrotomies closed successfully; no leakage

Minor injury to abdominal wall

Liu154

2014

Eagle Claw VIII

Gastrotomy closure

Porcine

17

17/17 2-cm gastrotomies closed successfully; no leakage; endoscopic suturing was superior to clip closure but inferior to hand-sewn techniques

NR

Mori155

2014 Double-arm bar suturing device

Gastrotomy closure

Porcine

10

10/10 40-mm gastrotomies closed successfully; no leakage; endoscopic suturing was superior to clip closure and equivalent to handsewn techniques for air leak

NR

Moustarah156

2013

Colotomy closure

Canine

9

9/10 successful 18-mm colotomy closures endoscopically; 8/8 closures intact at 2 wk

10% bleeding

Tissue apposition system

NR, Not reported; LES, lower esophageal sphincter; QOL, quality of life; RYGB, Roux-en-Y gastric bypass; PPi, proton pump inhibitor; ESD, endoscopic submucosal dissection; GJ, gastrojejunal; NOTES, natural orifice transluminal endoscopic surgery; GC, gastrocutaneous.

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TABLE 2. The number of articles reporting on each type of model Model

No. of articles

Human

64

Explant

3

Live

61

Animal

79

Baboon

1

Canine

7

Porcine

72

Explant

22

Live

53

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269.e19 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 2 : 2015

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Endoluminal flexible endoscopic suturing for minimally invasive therapies.

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