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.
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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
Volume 81, No. 2 : 2015 GASTROINTESTINAL ENDOSCOPY 269.e4
Endoluminal flexible endoscopic suturing for minimally invasive therapies
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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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Endoluminal flexible endoscopic suturing for minimally invasive therapies
Conway & Swanström
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
76
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Swanström & Conway
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
92
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Adverse Events
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Swanström & Conway
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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Conway & Swanström
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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Swanström & Conway
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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Swanström & Conway
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
269.e17 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 2 : 2015
75% abdominal pain and nausea, 25% acid reflux
10% adhesion
NR
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Endoluminal flexible endoscopic suturing for minimally invasive therapies
Conway & Swanström
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
Numbers may not sum as some articles report on multiple models.
269.e19 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 2 : 2015
www.giejournal.org