DDW HIGHLIGHTS
Endoscopy innovations Geoffroy Vanbiervliet,1,2 Jean-Michel Gonzalez,1,3 Marc Barthet1,3 Marseille, Nice, France
Innovation everywhere for everybodydthis is the way we can summarize the 2014 Digestive Disease Week, which was held in Chicago, Illinois, last May. Many sessions introduced new innovative materials and concepts. From the robot of the future to the simplest ideas, the congress was fertile and sometimes full of surprises. Abstracts representing significant progress and innovations in the field of digestive endoscopy are reviewed here.
DIAGNOSIS Optical coherence tomography (OCT) is now under the spotlight. This new technique can be useful to achieve realtime, 10-mm-resolution, and cross-sectional images of the different digestive segments.1 Barrett’s esophagus and associated dysplasia are accurately determined using this approach, which could reduce the sampling error of the random biopsy protocol during disease surveillance. Despite several in vivo OCT studies in the human gastrointestinal tract, the high cost and a lack of standardized terminology and large prospective data have limited the diffusion of this technique. An innovative, interesting, and simple application of OCT in the screening of Barrett’s esophagus was presented by Gora et al.2 The authors reported the first human experience using tethered capsule endomicroscopy in 53 patients. The device applied the OCT technology in a transparent capsule (11 25 mm) and was connected to a flexible tether (containing the optical fiber), which allowed its retrieval after swallowing. The entire esophagus
Abbreviations: CCE, colon capsule endoscopy; CTC, circulating tumoral cell; EMR, endoscopic mucosal resection; ESD, endoscopic submucosal dissection; EUS, endoscopic ultrasound; FNA, fine-needle aspiration; NOTES, natural orifice transluminal endoscopic surgery; OCT, optical coherence tomography; POEM, peroral endoscopic myotomy; SEMS, self-expanding metallic stents; TTNB, through-the-needle biopsy. DISCLOSURE: All authors disclosed no financial relationships relevant to this article. This report is published simultaneously in the journals Gastrointestinal Endoscopy and Endoscopy. Copyright ª 2014 by the American Society for Gastrointestinal Endoscopy and ª Georg Thieme Verlag KG 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2014.07.003
380 GASTROINTESTINAL ENDOSCOPY Volume 80, No. 3 : 2014
could be explored first via the peristalsis and then through the progressive withdrawal of the capsule. Furthermore, a coupled cautery laser light could be used to mark the regions of interest during the examination, which then facilitated their identification for conventional biopsy during subsequent high-definition video endoscopy. The capsule was successfully swallowed in 90% of cases, and the removal phase was the only uncomfortable step for patients. The marked Barrett’s esophagus and squamous sites were easily identified during subsequent video endoscopy. The procedure appeared to be safe and well tolerated, with a mean procedure time of approximately 10 minutes when three sites were marked. Thus, this new device appears to be a promising and useful alternative to gastroscopy in the surveillance of Barrett’s esophagus. Furthermore, it brings together several essential properties of a good screening test: simplicity, safety, tolerance, and diagnostic accuracy. A future validation study on 130 patients is currently underway by the same team prior to conducting a comparative and cost-effective analysis.
STENTING Despite the effectiveness of self-expanding metallic stents (SEMS) for the recovery of digestive patency in patients with malignant gastrointestinal obstructions, migration and tumoral ingrowth and overgrowth lead to significant dysfunction and re-intervention. Covered SEMS failed to achieve the highest patency in recent meta-analyses regardless of the stent location.3,4 Drugeluting stents are already used in cardiovascular treatments, and this material could open new gates in digestive stenting thanks to the potential for antitumor action. Promising preliminary results of safety and feasibility of the paclitaxel-eluting stent for malignant biliary obstructions have been published recently.5 Zhang and Zhining6 presented the first evaluation of paclitaxel-eluting covered metal stents in an animal model of obstructive esophageal squamous carcinoma. The authors used an interesting, previously developed, rabbit model of squamous cell carcinoma that induced a significant esophageal stricture by endoscopic implantation of VX2 fragments.7 The 30 animals were randomly assigned to receive either a noncovered SEMS or a paclitaxeleluting covered SEMS (at concentration 10%) to recover www.giejournal.org
Vanbiervliet et al
esophageal lumen patency. At sacrifice 2 weeks after stent placement, the paclitaxel-eluting SEMS group showed a significant reduction in both the mean tumor volume (0.94 vs. 7.0 cm3) and the area of the esophageal wall defect (0.17 vs. 0.7 cm2) compared with the noncovered SEMS. No difference in complications or adverse events was observed between the groups. The clinical outcomes (food intake, weight loss, and tumor metastasis) were similar, as would be expected for such a short follow-up. These results suggest a clear antitumor effect of the drug-eluting device with a potential improvement of stent patency. However, the stent occlusion rate did not differ when these devices were used in malignant biliary obstruction in the first human comparative studies.5 The concentration of paclitaxel and the adjuvant therapy (e.g. Pluronic F-127) contained in the membrane of the stent could explain the different results, because of variations in drug release.8 Large randomized and controlled clinical trials using various concentrations of coating agents are required in both the esophagus and other locations.
Endoscopy innovations
Safety could be an issue, as the device achieves a fullthickness suture in the absence of sufficient access in some locations. However, the results of this study are clearly promising, with only three significant complications reported, none of which required surgery (two esophageal tears and one bleeding needing transfusion). Furthermore, the large majority of the procedures were performed in an outpatient setting. In conclusion, the OverStitch suture appears to be safe and technically feasible. However, further clinical, randomized studies need to focus on efficacy and cost efficiency compared with other devices (e.g. over-thescope clips), other indications (e.g. complications after bariatric surgery), and other strategies used for the treatment of perforation or fistula. Finally, more data are awaited on longer follow-up as well as the persistence of the closure and suture over time.
VIDEO CAPSULE ENDOSCOPY
New therapeutic challenges in digestive endoscopy, such as natural orifice transluminal endoscopic surgery (NOTES), postsurgical leak and fistula, bariatric surgery, and complications of mucosal resection (endoscopic submucosal dissection [ESD] and endoscopic mucosal resection [EMR]), have led to the development of new suturing devices and techniques. However, the entire endoscopy field is still waiting for an easy, realistic, and suitable suturing tool. The Apollo OverStitch endoscopic suturing device (Apollo Endosurgery, Austin, Texas, United States) is definitely a good candidate judging by the large number of oral or poster communications on this topic during DDW. Recently, Kantsevoy et al9 reported the largest experience using the OverStitch in 12 consecutive patients, where large post-ESD defects were successfully closed within a short mean procedure time. At DDW, the first intermediate results of the US Nationwide Endoscopic Suturing Registry, in which the OverStitch full-thickness endoscopic suturing device was used, were presented.10 The system enables sutures to be placed through a flexible endoscope, without removing the endoscope for reloading and with a simple single-handed operation. This prospective observational multicenter study aimed to evaluate the feasibility and safety of the technique. To date, data from 284 procedures in 8 centers were collected. The operators were gastroenterologists and surgeons. Despite a patchwork of various indications (mainly transoral outlet reduction procedures n Z 181; leak and fistula n Z 42; and stent anchors n Z 37), the feasibility was confirmed and described as homogeneous, with only two unsuccessful procedures. The mean number of sutures was relatively low, varying from 1.5 to 4.2 depending on the etiology.
Bowel preparation remains a major factor of patient compliance in colorectal cancer screening. Less invasive and painless procedures such as colon capsule endoscopy (CCE) have not solved the problem because rigorous colon cleanliness and a booster to promote capsule transit are still required in order to achieve complete examination of the colon with better diagnostic accuracy before the end of the battery life.11 You dreamed about it, Moshkowitz and Arber12 made it! This team reported the first results of a novel prep-free colonic imaging capsule (Check Cap; Check Cap Ltd., Mount Carmel, Israel) in volunteers. The device is the same size as other optical capsule systems (11.5 34 mm) and delivers an ultra-low dose of roentgen rays, equivalent to a chest radiograph. After swallowing the capsule and a small amount of contrast agent, the patient continues their daily routine. The roentgen rays are generated at 360 around the device throughout the whole colon, and lesions are detected regardless of mucosal folds, stool, or a difficult location. The data are transmitted to a recorder, which provides threedimensional reconstruction of the colon images at the end of the procedure. Ten volunteers were enrolled to confirm the feasibility and safety of the technology in humans. The roentgen ray exposure was calculated and confirmed to be minimal (0.03 mSv). The average elimination time was 68 hours without any adverse event, and data were safely exported from the recorder. Laboratory synthetic and cow colon phantoms with or without polyps were also tested and showed reconstruction accuracy close to 2 mm in measurement. Thus, a high diagnostic accuracy for polyp screening is expected. This technology promises to be a simple, safe, efficient, and patient-friendly way of screening for colon cancer. A prospective multicenter study is ongoing to determine the efficacy in polyp detection, and results are eagerly awaited.
www.giejournal.org
Volume 80, No. 3 : 2014 GASTROINTESTINAL ENDOSCOPY 381
SUTURING DEVICES
Endoscopy innovations
ENDOSCOPIC ULTRASOUND STAGING There was no revolution or sophisticated technology in the field of endoscopic ultrasound (EUS) at DDW, but a new concept in staging the pancreatic cancer using EUS was presented. Recently, the detection of circulating tumoral cells (CTCs) in peripheral blood was suspected to precede detectable tumors in some precancerous cystic lesions.13 Consequently, CTC detection could be used as a biomarker in order to optimize the cancer risk stratification in pancreatic tumors. An early and accurate evaluation of resectability could be expected using this method and could improve the prognosis in cases of pancreatic cancer. However, CTC detection in peripheral blood is generally associated with a metastatic disease. Waxman et al14 proposed a pilot feasibility study for CTC detection in portal blood in 10 patients with suspected biliopancreatic cancer who were undergoing an EUS staging procedure. Portal vein sampling was achieved transhepatically under EUS guidance with a 19-gauge needle, as previously described by Giday et al.15 A sample of 8.5 mL of blood was sufficient to allow the analysis using a specific kit. Peripheral blood was also collected from each patient in order to compare the detection of CTCs with the portal site. EUS-guided fine-needle aspiration (FNA) of the suspected tumor was systematically performed following the portal sampling in order to determine the cytohistological diagnosis. The procedure was confirmed to be feasible in the entire enrolled population without any complication. All of the EUS-FNA results were positive for malignancy and 8/10 patients presented positive CTC detection in the portal sample, at a significantly higher rate compared with the peripheral blood (mean 71.8 vs. 0.3 CTCs). First, these results may suggest the common early disseminated status of the biliopancreatic cancer explaining its worse prognosis. However, this safe method could be proposed to accurately select resectable patients. Obviously, wider prospective studies should follow to confirm the place of CTC portal blood detection under EUS guidance during the pretherapeutic evaluation of the biliopancreatic malignancy.
Vanbiervliet et al
interest, therefore, in autoimmune pancreatitis, lymphoma, or subepithelial tumors. With this purpose, Nakai et al17 evaluated the use of a 0.075-mm biopsy forceps through a 19-gauge needle for EUS-guided sampling. In a pilot feasibility and safety study, they enrolled 14 patients with solid masses (12 pancreatic) who underwent EUS-FNA. First, the biopsy was performed under EUS guidance using the miniature forceps, which were preloaded into the needle instead of the stylet. The forceps were then withdrawn and an additional standard EUS-FNA was performed. All of the lesions were successfully sampled without significant complications. This new method using the forceps, called EUS-guided through-the-needle biopsy (TTNB), allowed a tissue core to be obtained in all cases (61% per passage). A single pass of the combined approach, EUS-TTNB and FNA, achieved a high diagnostic accuracy of 93% in malignant lesions. Furthermore, the benign lesions diagnosed were four autoimmune pancreatitis and one schwannoma, which usually present difficulty in EUS-sampling and cytohistological analysis. The main limitation of this technique will be the requirement for a large needle through which the biopsy forceps can be inserted. Indeed, the 19-gauge needle induces some technical difficulties and failures, particularly in the second part of the duodenum during the acquisition of cephalic or uncinated process pancreatic specimens. But the simplicity of the method and its instrumentation makes this diagnostic technique a new and interesting alternative in EUS-guided sampling, which must be more comprehensively studied in the future.
SUBMUCOSAL TUNNELING ENDOSCOPY
Optimization of the diagnostic performance of EUSguided sampling remains a key point in EUS-FNA. A new 19-gauge core biopsy needle was proposed in order to improve sample quality (ProCore; Wilson-Cook Medical, Winston Salem, North Carolina, United States), and yielded a final accuracy of 89.4% in cases of solid pancreatic lesion.16 However, in the same study, a tissue core could be observed in only 68% of the EUS samples. Obtaining a sample with complete and preserved histological architecture may be important, especially if immunohistochemical staining is required. Innovations in sampling techniques could be of
Submucosal endoscopic resection and myotomy techniques are developing dramatically worldwide, as confirmed by the high number of abstracts presented on this topic during DDW. The potential advantages are safer access, better exposure of the mucosal layer during dissection, and minimization of the risk of postoperative complications including air and fluid leakage (fistula, infection). Furthermore, it brings new challenging technical possibilities in interventional endoscopy, allowing full-thickness tumoral resections or NOTES access and could be named intraparietal interventional endoscopy or surgery. Peroral endoscopic myotomy (POEM) for achalasia was the first useful clinical application of this new discipline.18 Recently, the method was exceptionally proposed to treat a refractory gastroparesis by pyloromyotomy (gastric POEM).19 The surgical pyloroplasty is usually the gold standard technique performed for benign stenosis with gastric emptying disorders. Chaves et al20 presented their experience of gastric POEM in a one-case video during the “world cup of endoscopy” of a patient who developed gastroparesis after fundoplication. The different steps of the gastric
382 GASTROINTESTINAL ENDOSCOPY Volume 80, No. 3 : 2014
www.giejournal.org
ENDOSONOGRAPHY-GUIDED SAMPLING
Vanbiervliet et al
POEM procedure were similar to POEM for achalasia, using a proximal mucosal incision in the great curvature of the stomach after a submucosal injection. The submucosal dissection was then performed using a Flush Knife (Fujinon Optical Co., Ltd., Tokyo, Japan), and the pyloric muscle was perfectly exposed and easily sectioned. No complication was noted. Liquid intake was allowed for 2 days, followed by a soft diet for 5 days with ambulatory management. The efficacy of the procedure was confirmed by significant improvement in symptoms and gastric emptying scintigraphy. This new innovative application of submucosal myotomy offers a reliable alternative to different poor and disappointing noninvasive techniques that have been used to date (e.g. balloon dilation, botulinum toxin injection). Obviously, a prospective and large evaluation is now warranted before this procedure can be recommended for routine practice. REFERENCES 1. Kirtane TS, Wagh MS. Endoscopic optical coherence tomography (OCT): advances in gastrointestinal imaging. Gastroenterol Res Pract 2014;2014:376367. 2. Gora MJ, Soomr AR, Puricelli WP, et al. Unsedated screening for Barrett’s esophagus using tethered capsule endomicroscopy [abstract]. Gastrointest Endosc 2014;79(suppl 5):AB136. 3. Almadi MA, Barkun AN, Martel M. No benefit of covered vs uncovered self-expandable metal stents in patients with malignant distal biliary obstruction: a meta-analysis. Clin Gastroenterol Hepatol 2013;11: 27-37.e21. 4. Yang Z, Wu Q, Wang F, et al. A systematic review and meta-analysis of randomized trials and prospective studies comparing covered and bare self-expandable metal stents for the treatment of malignant obstruction in the digestive tract. Int J Med Sci 2013;10:825-35. 5. Song TJ, Lee SS, Yun SC, et al. Paclitaxel-eluting covered metal stents versus covered metal stents for distal malignant biliary obstruction: a prospective comparative pilot study. Gastrointest Endosc 2011;73: 727-33. 6. Zhang Y, Zhining F. Paclitaxel-eluting covered metal stents versus covered metal stents for esophageal squamous carcinoma in rabbits [abstract]. Gastrointest Endosc 2014;79(suppl 5):AB136. 7. Huang J, Zhang Y, Zhong H, et al. Comparison of endoscopic submucosal implantation vs. surgical intramuscular implantation of VX2 fragments for establishing a rabbit esophageal tumor model for mimicking human esophageal squamous carcinoma. PLoS One 2014;9:e85326.
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Endoscopy innovations 8. Jang SI, Kim JH, Kim M, et al. Porcine feasibility and safety study of a new paclitaxel-eluting biliary stent with a Pluronic-containing membrane. Endoscopy 2012;44:825-31. 9. Kantsevoy SV, Bitner M, Mitrakov AA, et al. Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos). Gastrointest Endosc 2014;79:503-7. 10. Kumar N, Ryan MB, Gostout CJ, et al. Nationwide Endoscopic Suturing Registry: interim activity report [abstract]. Gastrointest Endosc 2014;79(suppl 5):AB146. 11. Singhal S, Changela K, Lane D, et al. Endoscopic ultrasound-guided hepatic and perihepatic abscess drainage: an evolving technique. Therap Adv Gastroenterol 2014;7:93-8. 12. Moshkowitz N, Arber N. Safety and proof of concept demonstrated with a novel prep-less X-ray imaging capsule for colon cancer screening. Gastroenterology 2014;146(5 suppl 1):S142. 13. Rhim AD, Thege FI, Santana SM, et al. Detection of circulating pancreas epithelial cells in patients with pancreatic cystic lesions. Gastroenterology 2014;146:647-51. 14. Waxman I, Koons A, Konda VJ, et al. Detection of portal vein (PV) circulating tumor cells (CTCs) in pancreatic cancer (PC) patients obtained by EUS guided PV sampling. A safety and feasibility trial [abstract]. Gastrointest Endosc 2014;79(suppl 5):AB173. 15. Giday SA, Clarke JO, Buscaglia JM, et al. EUS-guided portal vein catheterization: a promising novel approach for portal angiography and portal vein pressure measurements. Gastrointest Endosc 2008;67:338-42. 16. Iglesias-Garcia J, Poley JW, Larghi A, et al. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc 2011;73:1189-96. 17. Nakai Y, Isayama H, Chang KJ, et al. A pilot study of EUS-guided through-the-needle biopsy (EUSTTNB) of solid masses [abstract]. Gastrointest Endosc 2014;79(suppl 5):AB175. 18. Inoue H, Minami H, Kobayashi Y, et al. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy 2010;42:265-71. 19. Khashab MA, Stein E, Clarke JO, et al. Gastric peroral endoscopic myotomy for refractory gastroparesis: first human endoscopic pyloromyotomy (with video). Gastrointest Endosc 2013;78:764-8. 20. Chaves DM, de Moura EG, Mestieri LH, et al. Endoscopic pyloromyotomy through a gastric submucosal tunnel dissection for the treatment of gastroparesis after surgical vagal lesion [abstract]. Gastrointest Endosc 2014;79(suppl 5):AB186. Received July 1, 2014. Accepted July 1, 2014. Current affiliations: Faculty of Medicine, Aix-Marseille University, Marseille (1), Gastroenterology, University Hospital of Nice, Nice (2), Gastroenterology, Public Assistance Hospitals of Marseille, Marseille, France (3). Reprint requests: Geoffroy Vanbiervliet, MD, MSc, Endoscopy unit, Gastroenterology, L’ARCHET 2 Hospital, 151 Route de Saint Antoine de Ginestière, CS 23079, 06202 Nice cedex 3, France.
Volume 80, No. 3 : 2014 GASTROINTESTINAL ENDOSCOPY 383
Endoscopy innovations Geoffroy Vanbiervliet,1,2 Jean-Michel Gonzalez,1,3 Marc Barthet1,3 Marseille, Nice, France
Innovation everywhere for everybodydthis is the way we can summarize the 2014 Digestive Disease Week, which was held in Chicago, Illinois, last May. Many sessions introduced new innovative materials and concepts. From the robot of the future to the simplest ideas, the congress was fertile and sometimes full of surprises. Abstracts representing significant progress and innovations in the field of digestive endoscopy are reviewed here.
DIAGNOSIS Optical coherence tomography (OCT) is now under the spotlight. This new technique can be useful to achieve realtime, 10-mm-resolution, and cross-sectional images of the different digestive segments.1 Barrett’s esophagus and associated dysplasia are accurately determined using this approach, which could reduce the sampling error of the random biopsy protocol during disease surveillance. Despite several in vivo OCT studies in the human gastrointestinal tract, the high cost and a lack of standardized terminology and large prospective data have limited the diffusion of this technique. An innovative, interesting, and simple application of OCT in the screening of Barrett’s esophagus was presented by Gora et al.2 The authors reported the first human experience using tethered capsule endomicroscopy in 53 patients. The device applied the OCT technology in a transparent capsule (11 25 mm) and was connected to a flexible tether (containing the optical fiber), which allowed its retrieval after swallowing. The entire esophagus
Abbreviations: CCE, colon capsule endoscopy; CTC, circulating tumoral cell; EMR, endoscopic mucosal resection; ESD, endoscopic submucosal dissection; EUS, endoscopic ultrasound; FNA, fine-needle aspiration; NOTES, natural orifice transluminal endoscopic surgery; OCT, optical coherence tomography; POEM, peroral endoscopic myotomy; SEMS, self-expanding metallic stents; TTNB, through-the-needle biopsy. DISCLOSURE: All authors disclosed no financial relationships relevant to this article. This report is published simultaneously in the journals Gastrointestinal Endoscopy and Endoscopy. Copyright ª 2014 by the American Society for Gastrointestinal Endoscopy and ª Georg Thieme Verlag KG 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2014.07.003
380 GASTROINTESTINAL ENDOSCOPY Volume 80, No. 3 : 2014
could be explored first via the peristalsis and then through the progressive withdrawal of the capsule. Furthermore, a coupled cautery laser light could be used to mark the regions of interest during the examination, which then facilitated their identification for conventional biopsy during subsequent high-definition video endoscopy. The capsule was successfully swallowed in 90% of cases, and the removal phase was the only uncomfortable step for patients. The marked Barrett’s esophagus and squamous sites were easily identified during subsequent video endoscopy. The procedure appeared to be safe and well tolerated, with a mean procedure time of approximately 10 minutes when three sites were marked. Thus, this new device appears to be a promising and useful alternative to gastroscopy in the surveillance of Barrett’s esophagus. Furthermore, it brings together several essential properties of a good screening test: simplicity, safety, tolerance, and diagnostic accuracy. A future validation study on 130 patients is currently underway by the same team prior to conducting a comparative and cost-effective analysis.
STENTING Despite the effectiveness of self-expanding metallic stents (SEMS) for the recovery of digestive patency in patients with malignant gastrointestinal obstructions, migration and tumoral ingrowth and overgrowth lead to significant dysfunction and re-intervention. Covered SEMS failed to achieve the highest patency in recent meta-analyses regardless of the stent location.3,4 Drugeluting stents are already used in cardiovascular treatments, and this material could open new gates in digestive stenting thanks to the potential for antitumor action. Promising preliminary results of safety and feasibility of the paclitaxel-eluting stent for malignant biliary obstructions have been published recently.5 Zhang and Zhining6 presented the first evaluation of paclitaxel-eluting covered metal stents in an animal model of obstructive esophageal squamous carcinoma. The authors used an interesting, previously developed, rabbit model of squamous cell carcinoma that induced a significant esophageal stricture by endoscopic implantation of VX2 fragments.7 The 30 animals were randomly assigned to receive either a noncovered SEMS or a paclitaxeleluting covered SEMS (at concentration 10%) to recover www.giejournal.org
Vanbiervliet et al
esophageal lumen patency. At sacrifice 2 weeks after stent placement, the paclitaxel-eluting SEMS group showed a significant reduction in both the mean tumor volume (0.94 vs. 7.0 cm3) and the area of the esophageal wall defect (0.17 vs. 0.7 cm2) compared with the noncovered SEMS. No difference in complications or adverse events was observed between the groups. The clinical outcomes (food intake, weight loss, and tumor metastasis) were similar, as would be expected for such a short follow-up. These results suggest a clear antitumor effect of the drug-eluting device with a potential improvement of stent patency. However, the stent occlusion rate did not differ when these devices were used in malignant biliary obstruction in the first human comparative studies.5 The concentration of paclitaxel and the adjuvant therapy (e.g. Pluronic F-127) contained in the membrane of the stent could explain the different results, because of variations in drug release.8 Large randomized and controlled clinical trials using various concentrations of coating agents are required in both the esophagus and other locations.
Endoscopy innovations
Safety could be an issue, as the device achieves a fullthickness suture in the absence of sufficient access in some locations. However, the results of this study are clearly promising, with only three significant complications reported, none of which required surgery (two esophageal tears and one bleeding needing transfusion). Furthermore, the large majority of the procedures were performed in an outpatient setting. In conclusion, the OverStitch suture appears to be safe and technically feasible. However, further clinical, randomized studies need to focus on efficacy and cost efficiency compared with other devices (e.g. over-thescope clips), other indications (e.g. complications after bariatric surgery), and other strategies used for the treatment of perforation or fistula. Finally, more data are awaited on longer follow-up as well as the persistence of the closure and suture over time.
VIDEO CAPSULE ENDOSCOPY
New therapeutic challenges in digestive endoscopy, such as natural orifice transluminal endoscopic surgery (NOTES), postsurgical leak and fistula, bariatric surgery, and complications of mucosal resection (endoscopic submucosal dissection [ESD] and endoscopic mucosal resection [EMR]), have led to the development of new suturing devices and techniques. However, the entire endoscopy field is still waiting for an easy, realistic, and suitable suturing tool. The Apollo OverStitch endoscopic suturing device (Apollo Endosurgery, Austin, Texas, United States) is definitely a good candidate judging by the large number of oral or poster communications on this topic during DDW. Recently, Kantsevoy et al9 reported the largest experience using the OverStitch in 12 consecutive patients, where large post-ESD defects were successfully closed within a short mean procedure time. At DDW, the first intermediate results of the US Nationwide Endoscopic Suturing Registry, in which the OverStitch full-thickness endoscopic suturing device was used, were presented.10 The system enables sutures to be placed through a flexible endoscope, without removing the endoscope for reloading and with a simple single-handed operation. This prospective observational multicenter study aimed to evaluate the feasibility and safety of the technique. To date, data from 284 procedures in 8 centers were collected. The operators were gastroenterologists and surgeons. Despite a patchwork of various indications (mainly transoral outlet reduction procedures n Z 181; leak and fistula n Z 42; and stent anchors n Z 37), the feasibility was confirmed and described as homogeneous, with only two unsuccessful procedures. The mean number of sutures was relatively low, varying from 1.5 to 4.2 depending on the etiology.
Bowel preparation remains a major factor of patient compliance in colorectal cancer screening. Less invasive and painless procedures such as colon capsule endoscopy (CCE) have not solved the problem because rigorous colon cleanliness and a booster to promote capsule transit are still required in order to achieve complete examination of the colon with better diagnostic accuracy before the end of the battery life.11 You dreamed about it, Moshkowitz and Arber12 made it! This team reported the first results of a novel prep-free colonic imaging capsule (Check Cap; Check Cap Ltd., Mount Carmel, Israel) in volunteers. The device is the same size as other optical capsule systems (11.5 34 mm) and delivers an ultra-low dose of roentgen rays, equivalent to a chest radiograph. After swallowing the capsule and a small amount of contrast agent, the patient continues their daily routine. The roentgen rays are generated at 360 around the device throughout the whole colon, and lesions are detected regardless of mucosal folds, stool, or a difficult location. The data are transmitted to a recorder, which provides threedimensional reconstruction of the colon images at the end of the procedure. Ten volunteers were enrolled to confirm the feasibility and safety of the technology in humans. The roentgen ray exposure was calculated and confirmed to be minimal (0.03 mSv). The average elimination time was 68 hours without any adverse event, and data were safely exported from the recorder. Laboratory synthetic and cow colon phantoms with or without polyps were also tested and showed reconstruction accuracy close to 2 mm in measurement. Thus, a high diagnostic accuracy for polyp screening is expected. This technology promises to be a simple, safe, efficient, and patient-friendly way of screening for colon cancer. A prospective multicenter study is ongoing to determine the efficacy in polyp detection, and results are eagerly awaited.
www.giejournal.org
Volume 80, No. 3 : 2014 GASTROINTESTINAL ENDOSCOPY 381
SUTURING DEVICES
Endoscopy innovations
ENDOSCOPIC ULTRASOUND STAGING There was no revolution or sophisticated technology in the field of endoscopic ultrasound (EUS) at DDW, but a new concept in staging the pancreatic cancer using EUS was presented. Recently, the detection of circulating tumoral cells (CTCs) in peripheral blood was suspected to precede detectable tumors in some precancerous cystic lesions.13 Consequently, CTC detection could be used as a biomarker in order to optimize the cancer risk stratification in pancreatic tumors. An early and accurate evaluation of resectability could be expected using this method and could improve the prognosis in cases of pancreatic cancer. However, CTC detection in peripheral blood is generally associated with a metastatic disease. Waxman et al14 proposed a pilot feasibility study for CTC detection in portal blood in 10 patients with suspected biliopancreatic cancer who were undergoing an EUS staging procedure. Portal vein sampling was achieved transhepatically under EUS guidance with a 19-gauge needle, as previously described by Giday et al.15 A sample of 8.5 mL of blood was sufficient to allow the analysis using a specific kit. Peripheral blood was also collected from each patient in order to compare the detection of CTCs with the portal site. EUS-guided fine-needle aspiration (FNA) of the suspected tumor was systematically performed following the portal sampling in order to determine the cytohistological diagnosis. The procedure was confirmed to be feasible in the entire enrolled population without any complication. All of the EUS-FNA results were positive for malignancy and 8/10 patients presented positive CTC detection in the portal sample, at a significantly higher rate compared with the peripheral blood (mean 71.8 vs. 0.3 CTCs). First, these results may suggest the common early disseminated status of the biliopancreatic cancer explaining its worse prognosis. However, this safe method could be proposed to accurately select resectable patients. Obviously, wider prospective studies should follow to confirm the place of CTC portal blood detection under EUS guidance during the pretherapeutic evaluation of the biliopancreatic malignancy.
Vanbiervliet et al
interest, therefore, in autoimmune pancreatitis, lymphoma, or subepithelial tumors. With this purpose, Nakai et al17 evaluated the use of a 0.075-mm biopsy forceps through a 19-gauge needle for EUS-guided sampling. In a pilot feasibility and safety study, they enrolled 14 patients with solid masses (12 pancreatic) who underwent EUS-FNA. First, the biopsy was performed under EUS guidance using the miniature forceps, which were preloaded into the needle instead of the stylet. The forceps were then withdrawn and an additional standard EUS-FNA was performed. All of the lesions were successfully sampled without significant complications. This new method using the forceps, called EUS-guided through-the-needle biopsy (TTNB), allowed a tissue core to be obtained in all cases (61% per passage). A single pass of the combined approach, EUS-TTNB and FNA, achieved a high diagnostic accuracy of 93% in malignant lesions. Furthermore, the benign lesions diagnosed were four autoimmune pancreatitis and one schwannoma, which usually present difficulty in EUS-sampling and cytohistological analysis. The main limitation of this technique will be the requirement for a large needle through which the biopsy forceps can be inserted. Indeed, the 19-gauge needle induces some technical difficulties and failures, particularly in the second part of the duodenum during the acquisition of cephalic or uncinated process pancreatic specimens. But the simplicity of the method and its instrumentation makes this diagnostic technique a new and interesting alternative in EUS-guided sampling, which must be more comprehensively studied in the future.
SUBMUCOSAL TUNNELING ENDOSCOPY
Optimization of the diagnostic performance of EUSguided sampling remains a key point in EUS-FNA. A new 19-gauge core biopsy needle was proposed in order to improve sample quality (ProCore; Wilson-Cook Medical, Winston Salem, North Carolina, United States), and yielded a final accuracy of 89.4% in cases of solid pancreatic lesion.16 However, in the same study, a tissue core could be observed in only 68% of the EUS samples. Obtaining a sample with complete and preserved histological architecture may be important, especially if immunohistochemical staining is required. Innovations in sampling techniques could be of
Submucosal endoscopic resection and myotomy techniques are developing dramatically worldwide, as confirmed by the high number of abstracts presented on this topic during DDW. The potential advantages are safer access, better exposure of the mucosal layer during dissection, and minimization of the risk of postoperative complications including air and fluid leakage (fistula, infection). Furthermore, it brings new challenging technical possibilities in interventional endoscopy, allowing full-thickness tumoral resections or NOTES access and could be named intraparietal interventional endoscopy or surgery. Peroral endoscopic myotomy (POEM) for achalasia was the first useful clinical application of this new discipline.18 Recently, the method was exceptionally proposed to treat a refractory gastroparesis by pyloromyotomy (gastric POEM).19 The surgical pyloroplasty is usually the gold standard technique performed for benign stenosis with gastric emptying disorders. Chaves et al20 presented their experience of gastric POEM in a one-case video during the “world cup of endoscopy” of a patient who developed gastroparesis after fundoplication. The different steps of the gastric
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POEM procedure were similar to POEM for achalasia, using a proximal mucosal incision in the great curvature of the stomach after a submucosal injection. The submucosal dissection was then performed using a Flush Knife (Fujinon Optical Co., Ltd., Tokyo, Japan), and the pyloric muscle was perfectly exposed and easily sectioned. No complication was noted. Liquid intake was allowed for 2 days, followed by a soft diet for 5 days with ambulatory management. The efficacy of the procedure was confirmed by significant improvement in symptoms and gastric emptying scintigraphy. This new innovative application of submucosal myotomy offers a reliable alternative to different poor and disappointing noninvasive techniques that have been used to date (e.g. balloon dilation, botulinum toxin injection). Obviously, a prospective and large evaluation is now warranted before this procedure can be recommended for routine practice. REFERENCES 1. Kirtane TS, Wagh MS. Endoscopic optical coherence tomography (OCT): advances in gastrointestinal imaging. Gastroenterol Res Pract 2014;2014:376367. 2. Gora MJ, Soomr AR, Puricelli WP, et al. Unsedated screening for Barrett’s esophagus using tethered capsule endomicroscopy [abstract]. Gastrointest Endosc 2014;79(suppl 5):AB136. 3. Almadi MA, Barkun AN, Martel M. No benefit of covered vs uncovered self-expandable metal stents in patients with malignant distal biliary obstruction: a meta-analysis. Clin Gastroenterol Hepatol 2013;11: 27-37.e21. 4. Yang Z, Wu Q, Wang F, et al. A systematic review and meta-analysis of randomized trials and prospective studies comparing covered and bare self-expandable metal stents for the treatment of malignant obstruction in the digestive tract. Int J Med Sci 2013;10:825-35. 5. Song TJ, Lee SS, Yun SC, et al. Paclitaxel-eluting covered metal stents versus covered metal stents for distal malignant biliary obstruction: a prospective comparative pilot study. Gastrointest Endosc 2011;73: 727-33. 6. Zhang Y, Zhining F. Paclitaxel-eluting covered metal stents versus covered metal stents for esophageal squamous carcinoma in rabbits [abstract]. Gastrointest Endosc 2014;79(suppl 5):AB136. 7. Huang J, Zhang Y, Zhong H, et al. Comparison of endoscopic submucosal implantation vs. surgical intramuscular implantation of VX2 fragments for establishing a rabbit esophageal tumor model for mimicking human esophageal squamous carcinoma. PLoS One 2014;9:e85326.
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Endoscopy innovations 8. Jang SI, Kim JH, Kim M, et al. Porcine feasibility and safety study of a new paclitaxel-eluting biliary stent with a Pluronic-containing membrane. Endoscopy 2012;44:825-31. 9. Kantsevoy SV, Bitner M, Mitrakov AA, et al. Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos). Gastrointest Endosc 2014;79:503-7. 10. Kumar N, Ryan MB, Gostout CJ, et al. Nationwide Endoscopic Suturing Registry: interim activity report [abstract]. Gastrointest Endosc 2014;79(suppl 5):AB146. 11. Singhal S, Changela K, Lane D, et al. Endoscopic ultrasound-guided hepatic and perihepatic abscess drainage: an evolving technique. Therap Adv Gastroenterol 2014;7:93-8. 12. Moshkowitz N, Arber N. Safety and proof of concept demonstrated with a novel prep-less X-ray imaging capsule for colon cancer screening. Gastroenterology 2014;146(5 suppl 1):S142. 13. Rhim AD, Thege FI, Santana SM, et al. Detection of circulating pancreas epithelial cells in patients with pancreatic cystic lesions. Gastroenterology 2014;146:647-51. 14. Waxman I, Koons A, Konda VJ, et al. Detection of portal vein (PV) circulating tumor cells (CTCs) in pancreatic cancer (PC) patients obtained by EUS guided PV sampling. A safety and feasibility trial [abstract]. Gastrointest Endosc 2014;79(suppl 5):AB173. 15. Giday SA, Clarke JO, Buscaglia JM, et al. EUS-guided portal vein catheterization: a promising novel approach for portal angiography and portal vein pressure measurements. Gastrointest Endosc 2008;67:338-42. 16. Iglesias-Garcia J, Poley JW, Larghi A, et al. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc 2011;73:1189-96. 17. Nakai Y, Isayama H, Chang KJ, et al. A pilot study of EUS-guided through-the-needle biopsy (EUSTTNB) of solid masses [abstract]. Gastrointest Endosc 2014;79(suppl 5):AB175. 18. Inoue H, Minami H, Kobayashi Y, et al. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy 2010;42:265-71. 19. Khashab MA, Stein E, Clarke JO, et al. Gastric peroral endoscopic myotomy for refractory gastroparesis: first human endoscopic pyloromyotomy (with video). Gastrointest Endosc 2013;78:764-8. 20. Chaves DM, de Moura EG, Mestieri LH, et al. Endoscopic pyloromyotomy through a gastric submucosal tunnel dissection for the treatment of gastroparesis after surgical vagal lesion [abstract]. Gastrointest Endosc 2014;79(suppl 5):AB186. Received July 1, 2014. Accepted July 1, 2014. Current affiliations: Faculty of Medicine, Aix-Marseille University, Marseille (1), Gastroenterology, University Hospital of Nice, Nice (2), Gastroenterology, Public Assistance Hospitals of Marseille, Marseille, France (3). Reprint requests: Geoffroy Vanbiervliet, MD, MSc, Endoscopy unit, Gastroenterology, L’ARCHET 2 Hospital, 151 Route de Saint Antoine de Ginestière, CS 23079, 06202 Nice cedex 3, France.
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