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Efficacy of the Ovesco Clip for Closure of Endoscope Related Perforations. DIAGNOSTIC AND THERAPEUTIC ENDOSCOPY 2016; 2016:9371878. [PMID: 27293368 PMCID: PMC4884865 DOI: 10.1155/2016/9371878] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 03/04/2016] [Accepted: 05/03/2016] [Indexed: 02/06/2023]
Abstract
Aim. To study the efficacy and other treatment outcomes of Ovesco clip closure of iatrogenic perforation. Methods. Retrospective study from 3 tertiary-care hospitals in Thailand. Patients with iatrogenic perforation who underwent immediate endoscopic closure by Ovesco clip were included. Patients' demographic data, perforation size, number of Ovesco clips used, fasting day, length of hospital stay, success rates, and complication rate were recorded. Technical success was defined as closure achievement during endoscopic procedure and clinical success was defined as the patient can be discharged without the need of additional surgical or radiological intervention. Results. There were 6 iatrogenic perforations in 2 male and 4 female patients. The median age was 59 years (range 39-78 years). The locations of perforation were 5 duodenal walls and 1 rectosigmoid junction. The median perforation size was 13 mm (range 10-40 mm). The technical success was 100% and the clinical success was 83.3%. The success rates per locations were 100% in colon and 80% in duodenum, respectively. The median fasting time was 5 days (range 1-10 days) and the median length of hospital stay was 10 days (range 2-22 days). There was no mortality in any. Conclusion. Ovesco clip seems to be an effective and safe tool for a closure of iatrogenic perforation.
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Wedi E, Gonzalez S, Menke D, Kruse E, Matthes K, Hochberger J. One hundred and one over-the-scope-clip applications for severe gastrointestinal bleeding, leaks and fistulas. World J Gastroenterol 2016; 22:1844-1853. [PMID: 26855543 PMCID: PMC4724615 DOI: 10.3748/wjg.v22.i5.1844] [Citation(s) in RCA: 73] [Impact Index Per Article: 8.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/30/2015] [Revised: 09/27/2015] [Accepted: 12/01/2015] [Indexed: 02/06/2023] Open
Abstract
AIM: To investigate the efficacy and clinical outcome of patients treated with an over-the-scope-clip (OTSC) system for severe gastrointestinal hemorrhage, perforations and fistulas.
METHODS: From 02-2009 to 10-2012, 84 patients were treated with 101 OTSC clips. 41 patients (48.8%) presented with severe upper-gastrointestinal (GI) bleeding, 3 (3.6%) patients with lower-GI bleeding, 7 patients (8.3%) underwent perforation closure, 18 patients (21.4%) had prevention of secondary perforation, 12 patients (14.3%) had control of secondary bleeding after endoscopic mucosal resection or endoscopic submucosal dissection (ESD) and 3 patients (3.6%) had an intervention on a chronic fistula.
RESULTS: In 78/84 patients (92.8%), primary treatment with the OTSC was technically successful. Clinical primary success was achieved in 75/84 patients (89.28%). The overall mortality in the study patients was 11/84 (13.1%) and was seen in patients with life threatning upper GI hemorrhage. There was no mortality in any other treatment group. In detail OTSC application lead to a clinical success in 35/41 (85.36%) patients with upper GI bleeding and in 3/3 patients with lower GI bleeding. Technical success of perforation closure was 100% while clinical success was seen in 4/7 cases (57.14%) due to attendant circumstances unrelated to the OTSC. Technical and clinic success was achieved in 18/18 (100%) patients for the prevention of bleeding or perforation after endoscopic mucosal resection and ESD and in 3/3 cases of fistula closure. Two application-related complications were seen (2%).
CONCLUSION: This largest single center experience published so far confirms the value of the OTSC for GI emergencies and complications. Further clinical experience will help to identify optimal indications for its targeted and prophylactic use.
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Donatsky AM, Andersen L, Nielsen OL, Meisner S, Jørgensen LN, Rosenberg J, Vilmann P. Gastrotomy Healing After Transgastric Peritoneoscopy: A Randomized Study in a Pig Model. J Laparoendosc Adv Surg Tech A 2015; 25:747-54. [PMID: 26275155 DOI: 10.1089/lap.2015.0271] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/12/2022] Open
Abstract
INTRODUCTION Reliable closure and infection prevention are the main barriers for implementation of pure transgastric peritoneoscopy. The primary aim of this study was to assess healing of over the scope clip (OTSC) closed gastrotomies. MATERIALS AND METHODS Pure transgastric peritoneoscopy was performed in 7 pigs. The pigs were randomized to 14 or 28 postoperative days (POD) of follow-up. Decontamination of the access route was performed before instrumentation. A full necropsy was performed. Closure was evaluated with histopathological examination of excised gastrorrhaphies. RESULTS Three pigs were allowed 14 POD of follow-up, and 4 pigs were allowed 28 POD of follow-up. Survival was achieved in 6 of the 7 animals; 1 pig was euthanized due to diffuse peritonitis. Based on our definition, full-thickness healing had only been achieved in a single pig allowed 28 POD. With respect to clinical relevancy, full-thickness healing was deemed achieved in 4 of 6 pigs completing follow-up and in all pigs allowed and surviving 28 POD. Access required repeated punctures and the use of several endoscopic instruments. CONCLUSIONS Full-thickness healing of the gastrotomy was only found in a single case when adhering to the per protocol definition. Endoscopic ultrasonography-guided access was difficult. It lacks reproducibility and needs refinement. Despite a combined decontamination regimen, infectious complications still occurred.
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Affiliation(s)
- Anders Meller Donatsky
- 1 Department of Surgery, Hvidovre Hospital, University of Copenhagen , Hvidovre, Denmark
| | - Luise Andersen
- 2 Department of Pathology, Roskilde Hospital, University of Copenhagen , Roskilde, Denmark
| | - Ole Lerberg Nielsen
- 3 Department of Veterinary Disease Biology, Faculty of Health and Medical Sciences, University of Copenhagen , Frederiksberg, Denmark
| | - Søren Meisner
- 4 Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen , Copenhagen, Denmark
| | | | - Jacob Rosenberg
- 5 Department of Surgery, Herlev Hospital, University of Copenhagen , Herlev, Denmark
| | - Peter Vilmann
- 5 Department of Surgery, Herlev Hospital, University of Copenhagen , Herlev, Denmark
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Singhal S, Changela K, Culliford A, Duddempudi S, Krishnaiah M, Anand S. Endoscopic closure of persistent gastrocutaneous fistulae, after percutaneous endoscopic gastrostomy (PEG) tube placement, using the over-the-scope-clip system. Therap Adv Gastroenterol 2015; 8:182-8. [PMID: 26136836 PMCID: PMC4480569 DOI: 10.1177/1756283x15578603] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023] Open
Abstract
OBJECTIVES The Over-The-Scope-Clip (OTSC) has had an evolving role in endoscopic closure of gastrointestinal wall defects, in hemostasis of primary or postinterventional bleeding, and approximation of postbariatric surgery defects. Rapid and effective closure of gastrocutaneous (GC) fistulae using this device has been recently described in the literature. The aim of this study was to evaluate the technical feasibility, efficacy and safety of OTSC as an effective tool in the management of persistent GC fistulae secondary to a complication of percutaneous endoscopic gastrostomy (PEG) tube placement. METHOD In this multicenter prospective observational study, we describe our experience with OTSC in the closure of persistent GC fistulas secondary to PEG tube placement. Patients with GC fistulas were sequentially enrolled with a mean age of 84 years. Primary treatment outcome was the immediate successful closure of GC fistula and resolution of leak. Secondary outcome was no recurrence of the fistula and leaks on follow up. RESULTS A total of 10 patients were enrolled over the study period. Mean age was 84.4 ± 8.75 years. The primary treatment outcome was achieved in all the patients undergoing this intervention. Secondary outcome was observed in 9/10 (90%) subjects. No procedural complications were reported. Larger fistulae (>2.5 cm) and those with significant fibrosis were more difficult to close with the OTSC system. The mean follow-up time after OTSC application was 43.7 ± 20.57 days. A limitation of this study was that there was no control group. CONCLUSIONS OTSC application is a safe and effective endoscopic approach for the closure of persistent GC fistulae secondary to a complication of PEG tube placement.
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Affiliation(s)
- Shashideep Singhal
- Division of Gastroenterology, The Brooklyn Hospital Center, New York Presbyterian Healthcare System, 121 Dekalb Ave, Brooklyn, NY 11201, USA
| | - Kinesh Changela
- Division of Gastroenterology, The Brooklyn Hospital Center, New York Presbyterian Healthcare System, Brooklyn NY, USA
| | - Andrea Culliford
- Division of Gastroenterology, St Barnabas Hospital, Bronx, NY, USA
| | - Sushil Duddempudi
- Division of Gastroenterology, The Brooklyn Hospital Center, New York Presbyterian Healthcare System, Brooklyn NY, USA
| | - Mahesh Krishnaiah
- Division of Gastroenterology, The Brooklyn Hospital Center, New York Presbyterian Healthcare System, Brooklyn NY, USA
| | - Sury Anand
- Division of Gastroenterology, The Brooklyn Hospital Center, New York Presbyterian Healthcare System, Brooklyn NY, USA
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Natural orifice transluminal endoscopic surgery in humans: feasibility and safety of transgastric closure using the OTSC system. Surg Endosc 2015; 30:73-7. [PMID: 25801110 DOI: 10.1007/s00464-015-4163-4] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/16/2014] [Accepted: 03/09/2015] [Indexed: 12/12/2022]
Abstract
BACKGROUND NOTES is a technique in which an operation is performed within the body without a skin incision by using a natural body orifice to provide access. The principal challenge of transgastric NOTES procedures is still the feasibility and safety of access closure. Currently, there are very limited data regarding the closure of transgastric NOTES in humans, and the standard method and device for closure has not been defined. Herein, we evaluate the feasibility and safety of gastric closure after NOTES procedures in humans with the over-the-scope clip (OTSC). METHODS Review of collected data of patients underwent transgastric NOTES in prospective clinical studies between April 2010 and March 2014 focused on the gastric closure with the OTSC. RESULTS A total of 43 patients underwent transgastric NOTES 36 patients with an acute appendicitis, six patients with a prophylactic bilateral salpingo-oophorectomy, and one patient with uterus myomatosus. In all 43 cases, the incision of the gastric wall and the endoscopic access to the abdominal cavity succeeded without any difficulty. After performing transgastric procedures, it was possible to close the access by OTSC in all cases. There were all in all three adverse events: one major (Clavien-Dindo Grade III) and two minor (Clavien-Dindo Grades I and II). CONCLUSION Even if we could show for the first time in more than 40 consecutive patients that there is a safe approach for closing the transgastric access, it is absolutely necessary that further investigation in clinical settings has to be done to establish clear indications and guidelines for the use of transgastric NOTES.
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Feussner H, Becker V, Bauer M, Kranzfelder M, Schirren R, Lüth T, Meining A, Wilhelm D. Developments in flexible endoscopic surgery: a review. Clin Exp Gastroenterol 2014; 8:31-42. [PMID: 25565878 PMCID: PMC4278730 DOI: 10.2147/ceg.s46584] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/17/2022] Open
Abstract
Flexible endoscopy is increasingly developing into a therapeutic instead of a purely diagnostic discipline. Improved visualization makes early lesions easily detectable and allows us to decide ad hoc on the required treatment. Deep enteroscopy allows the exploration of even the small bowel - for long a "white spot" for gastrointestinal endoscopy - and to perform direct treatment. Endoscopic submucosal dissection is a considerable step forward in oncologically correct endoscopic treatment of (early) malignant lesions. Though still technically challenging, it is increasingly facilitated by new manipulation techniques and tools that are being steadily optimized. Closure of wall defects and hemostasis could be improved significantly. Even the anatomy beyond the gastrointestinal wall is being explored by the therapeutic use of endoluminal ultrasound. Endosonographic-guided surgery is not only a suitable fallback solution if conventional endoscopic retrograde cholangiopancreatography fails, but even makes necrosectomy procedures, abscess drainage, and neurolysis feasible for the endoscopist. Newly developed endoscopic approaches aim at formerly distinctive surgical domains like gastroesophageal reflux disease, appendicitis, and cholecystitis. Combined endoscopic/laparoscopic interventional techniques could become the harbingers of natural orifice transluminal endoscopic surgery, whereas pure natural orifice transluminal endoscopic surgery is currently still in its beginnings.
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Affiliation(s)
- Hubertus Feussner
- Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Germany
| | - Valentin Becker
- 2nd Medical Department, Klinikum rechts der Isar, Technische Universität München, Germany
| | - Margit Bauer
- Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Germany
| | - Michael Kranzfelder
- Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Germany
| | - Rebekka Schirren
- Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Germany
| | - Tim Lüth
- Institute of Microtechnology and Medical Device Technology, Klinikum rechts der Isar, Technische Universität München, Germany
| | - Alexander Meining
- 2nd Medical Department, Klinikum rechts der Isar, Technische Universität München, Germany
| | - Dirk Wilhelm
- Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Germany
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Arezzo A. The past, the present, and the future of minimally invasive therapy in laparoscopic surgery: A review and speculative outlook. MINIM INVASIV THER 2014; 23:253-60. [DOI: 10.3109/13645706.2014.900084] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
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Lee WC, Ko WJ, Cho JH, Lee TH, Jeon SR, Kim HG, Cho JY. Endoscopic Treatment of Various Gastrointestinal Tract Defects with an Over-the-Scope Clip: Case Series from a Tertiary Referral Hospital. Clin Endosc 2014; 47:178-182. [PMID: 24765601 PMCID: PMC3994261 DOI: 10.5946/ce.2014.47.2.178] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/05/2013] [Revised: 03/28/2013] [Accepted: 03/28/2013] [Indexed: 12/12/2022] Open
Abstract
Recently, increasingly invasive therapeutic endoscopic procedures and more complex gastrointestinal surgeries such as endoscopic mucosal resection, endoscopic submucosal dissection, and novel laparoscopic approaches have resulted in endoscopists being confronted more frequently with perforations, fistulas, and anastomotic leakages, for which nonsurgical closure is desired. In this article, we present our experiences with the use of over-the-scope clip (OTSC) for natural orifice transluminal endoscopic surgery (NOTES) closure, prevention of perforation, anastomotic leakages, and fistula closures. The OTSC is a valuable device for closing intestinal perforations and fistulas, for NOTES closure, and for the prevention of perforation after the excision of a tumor from the proper muscle layer. Furthermore, it seems to be quite safe to perform, even by endoscopists with little experience of the technique.
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Affiliation(s)
- Woong Cheul Lee
- Digestive Disease Center, Soonchunhyang University Hospital, Seoul, Korea
| | - Weon Jin Ko
- Digestive Disease Center, Soonchunhyang University Hospital, Seoul, Korea
| | - Jun-Hyung Cho
- Digestive Disease Center, Soonchunhyang University Hospital, Seoul, Korea
| | - Tae Hee Lee
- Digestive Disease Center, Soonchunhyang University Hospital, Seoul, Korea
| | - Seong Ran Jeon
- Digestive Disease Center, Soonchunhyang University Hospital, Seoul, Korea
| | - Hyun Gun Kim
- Digestive Disease Center, Soonchunhyang University Hospital, Seoul, Korea
| | - Joo Young Cho
- Digestive Disease Center, Soonchunhyang University Hospital, Seoul, Korea
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Arezzo A, Zornig C, Mofid H, Fuchs KH, Breithaupt W, Noguera J, Kaehler G, Magdeburg R, Perretta S, Dallemagne B, Marescaux J, Copaescu C, Graur F, Szasz A, Forgione A, Pugliese R, Buess G, Bhattacharjee HK, Navarra G, Godina M, Shishin K, Morino M. The EURO-NOTES clinical registry for natural orifice transluminal endoscopic surgery: a 2-year activity report. Surg Endosc 2013; 27:3073-3084. [PMID: 23519494 DOI: 10.1007/s00464-013-2908-5] [Citation(s) in RCA: 43] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/11/2012] [Accepted: 02/12/2013] [Indexed: 01/05/2023]
Abstract
BACKGROUND The EURO-NOTES Clinical Registry (ECR) was established as a European database to allow the monitoring and safe introduction of Natural Orifice Transluminal Endoscopic Surgery (NOTES). The aim of this study was to analyze different techniques applied and relative results during the first 2 years of the ECR. METHODS The ECR was designed as a voluntary database with online access. All members of the European Society for Gastrointestinal Endoscopy and the European Association for Endoscopic Surgery were requested to participate in the registry. Demographic and therapy data as well as data on the postoperative course are recorded in the ECR in an anonymous way. RESULTS A total of 533 patients who underwent NOTES procedures were included in the study. Four different hybrid techniques for 435 cholecystectomies were described, registering postoperative complications in 2.8% of patients, addition of a single trocar in 5.3%, and conversions to laparoscopy in 0.5%. Both flexible endoscopic and rigid laparoscopic cholecystectomy techniques proved to be safe and effective with minor differences. There was a shorter operative time in the rigid laparoscopic group. Thirty-three appendectomies were reported by transgastric and transvaginal techniques, with transvaginal techniques scoring shorter operative time and hospital stay, but with a frequent need to add more trocars. Overall complications occurred in 14.7% of patients but they did not differ significantly among the different techniques. One transvaginal and 31 transanal sigmoidectomies were included for prolapse and diverticulitis, with four postoperative complications (12.5%), but none needing further treatment. Twenty peroral esophageal myotomies were included with three postoperative complications (15.0%), but none needing further treatment. CONCLUSIONS Five years since the introduction of NOTES into clinical practice, hybrid techniques have gained considerable clinical application. Several NOTES hybrid cholecystectomy and appendectomy techniques are practicable and safe alternatives to laparoscopic procedures. Also, sigmoidectomies and peroral esophageal myotomies were described, proving feasibility and safety. Nevertheless, the real benefit of NOTES for patients still needs to be assessed.
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Affiliation(s)
- Alberto Arezzo
- Department of Surgical Sciences, University of Turin, Corso Dogliotti 14, 10126 Turin, Italy.
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Li L, Wang F, Wu B, Wang Q, Wang C, Liu J. Endoscopic submucosal dissection of gastric fundus subepithelial tumors originating from the muscularis propria. Exp Ther Med 2013; 6:391-395. [PMID: 24137195 PMCID: PMC3786878 DOI: 10.3892/etm.2013.1181] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2013] [Accepted: 06/14/2013] [Indexed: 12/18/2022] Open
Abstract
Endoscopic resection of gastric subepithelial tumors (SETs) carries a high risk of perforation, particularly for tumors located at the gastric fundus and originating from the muscularis propria. Based on our experience with endoscopic submucosal dissection (ESD) and a novel endoscopic device, namely the ‘Resolution clip’ for the endoscopic closure of iatrogenic upper gastrointestinal (upper GI) perforations, we evaluated the clinical feasibility and safety of ESD for gastric fundus subepithelial tumors originating from the muscularis propria. In this prospective study, 11 consecutive patients who presented with gastric SETs ≤3 cm in diameter were enrolled. Regardless of whether perforation occurred, the gastric wall defect was closed with clips. The patients were followed up after the surgery. Endoscopic resection was successfully performed in 10 patients; however, in one patient a pure endoscopic approach was impossible as the lesion was severely adhered to surrounding tissue, and a switch to laparoscopic wedge resection was necessary. The mean resected tumor size was 18.8×17.2 mm and the mean surgery time of the 10 patients with ESD was 81 min (range 45–130 min). Histological diagnosis was gastrointestinal stromal tumor (GIST) in eight lesions [very low risk according to the National Institutes of Health (NIH) risk classification] and leiomyoma in three lesions. Perforation occurred in 3/10 patients. Gastric closure with the Resolution clips was performed successfully in all cases. Early post-ESD bleeding (EPEB) occurred in one patient. Basic ferric sulfate solution was sprayed during the upper GI endoscopy examination and the bleeding stopped. No complications occurred and the follow-up was unremarkable. In this early study, ESD using the Resolution clip was demonstrated to be a feasible and minimally invasive treatment for gastric fundus subepithelial tumors originating from the muscularis propria.
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Affiliation(s)
- Lei Li
- Department of Gastroenterology, Shandong Provincial Hospital, Shandong University, Jinan, Shandong 250021; ; Department of Gastroenterology, Taian Central Hospital, Taian, Shandong 271000, P.R. China
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Weiland T, Fehlker M, Gottwald T, Schurr MO. Performance of the OTSC System in the endoscopic closure of iatrogenic gastrointestinal perforations: a systematic review. Surg Endosc 2013; 27:2258-74. [PMID: 23340813 DOI: 10.1007/s00464-012-2754-x] [Citation(s) in RCA: 106] [Impact Index Per Article: 8.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/06/2012] [Accepted: 11/22/2012] [Indexed: 12/17/2022]
Abstract
BACKGROUND Reliable closure is a prerequisite for conventional and innovative endoscopic procedures, such as NOTES. The purpose of this study is the systematic evaluation of the procedural and clinical success rates in closure of iatrogenic gastrointestinal perforations and acute anastomotic leaks by means of the over-the-scope-clip system (OTSC(®)). DESIGN PubMed and other sources were searched systematically for clinical and preclinical research on the evaluation of the OTSC System for closure of gastrointestinal perforations and leaks. Appraisal of studies for inclusion and data extraction was performed independently by two reviewers using an a priori determined data extraction grid. Major endpoints to be extracted were data on procedural success (successful clip application) and clinical access (durable closure of defect without secondary adjunct therapy). RESULTS A total of 17 clinical research articles/abstracts and 22 preclinical research articles/abstracts were identified. The examined clinical studies comprised case series and clinical single-arm studies. The reviewed studies revealed a consistently high mean rate of procedural success of 80-100 % and durable clinical success of 57-100 %. An identified major drawback preventing successful clip application was occurrence of fibrotic or inflamed lesion edges. Usage of the OTSC System was accompanied by neither major clip-related nor application-related complication. In experimental settings, closure of larger perforations and gastric access sites of NOTES or endoscopic full-thickness resection were achieved with high rates of success. CONCLUSIONS Because randomized, clinical trials are not available in this field of indication, the evaluation is based on small case series. Nevertheless, by pooling all experience gained, we conclude that endoscopic closure of iatrogenic gastrointestinal perforations and acute anastomotic leaks by means of the OTSC System is a safe and effective method.
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Zhang XL, Qu JH, Sun G, Tang P, Yang YS. Feasibility study of secure closure of gastric fundus perforation using over-the-scope clips in a dog model. J Gastroenterol Hepatol 2012; 27:1200-4. [PMID: 22507171 DOI: 10.1111/j.1440-1746.2012.07156.x] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/27/2023]
Abstract
BACKGROUND AND AIM Gastric fundus perforation is a serious complication of endoscopic mucosal resection and endoscopic submucosal dissection performed for the removal of early gastric cancers or subepithelial tumors. The novel over-the-scope clip (OTSC) has recently been found to be effective for closing gastrointestinal-tract perforations and accesses for natural orifice transluminal endoscopic surgery. However, feasibility studies of OTSCs in gastric fundus perforation are still lacking. The aim of this study was therefore to demonstrate the feasibility of endoscopic closure of gastric fundus perforation using the OTSC system in a dog model. METHODS Gastric fundus perforations were created by needle-knife electrocautery in seven dogs. The perforations were then closed using the OTSC clipping system. Stomach distension was maintained by maximum insufflation with air and methylene blue solution (500 mL) was instilled to submerge the closed perforation. Leaks were detected laparoscopically. RESULTS Perforations were closed in all seven cases with a mean time of 18.5 ± 6.4 min (11-28 min). Twin Grasper assistance failed to release the OTSCs in two of the seven cases (2/7, 28.6%) because of difficulties associated with the J-maneuver (retroflexion of endoscope) required for the gastric fundus procedure, and OTCS were forced into place by suction. Minor leakage was observed in one case (1/7, 14.3%). No damages related to the clip system were found during postmortem examinations. CONCLUSIONS Despite difficulties associated with the J-maneuver of the endoscope, this small series demonstrated that sufficient closure of gastric fundus perforation could be achieved using the OTSC system.
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Affiliation(s)
- Xiu-Li Zhang
- Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Beijing, China
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13
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Donatsky AM, Andersen L, Nielsen OL, Holzknecht BJ, Vilmann P, Meisner S, Jørgensen LN, Rosenberg J. Pure natural orifice transluminal endoscopic surgery (NOTES) with ultrasonography-guided transgastric access and over-the-scope-clip closure: a porcine feasibility and survival study. Surg Endosc 2012; 26:1952-62. [PMID: 22237757 DOI: 10.1007/s00464-011-2135-x] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/23/2011] [Accepted: 12/13/2011] [Indexed: 12/16/2022]
Abstract
BACKGROUND Most natural orifice transluminal endoscopic surgery (NOTES) procedures to date rely on the hybrid technique with simultaneous laparoscopic access to protect against access-related complications and to achieve adequate triangulation for dissection. This is done at the cost of the potential benefits of this new minimally invasive technique. This study aimed to evaluate the feasibility and safety of a transgastric (TG) pure-NOTES procedure in a diagnostic setting. METHODS A TG pure-NOTES procedure with endoscopic ultrasonograpy (EUS)-guided access and over-the-scope-clip (OTSC) closure was performed for 10 pigs in a survival and feasibility study. A full macroscopic necropsy with subsequent histologic evaluation was performed on postoperative day (POD) 14. The outcome parameters were uncomplicated follow-up assessment, survival, intraoperative complications, intraabdominal pathology, macroscopic full-thickness closure, and histology-proven full-thickness healing of the gastrotomy. RESULTS An uncomplicated postoperative course was reported for 9 of the 10 pigs, and survival was reported for all 10 pigs. For all the pigs, EUS-guided access was performed successfully with a median duration of 25 min (range, 12-62 min) and without intraoperative complications or access-related lesions at necropsy. An OTSC closure was achieved with a median duration of 11 min (range, 3-28 min). The OTSC provided immediate closure, but according to the authors' definition of a full-thickness healing evaluated by histologic examination, this was not achieved in any of the cases. Although all the animals survived until POD 14, intraabdominal chronic abscesses were present in 3 of the 10 pigs at necropsy. CONCLUSIONS The EUS-guided TG access proved to be feasible without access-related complications. Although OTSC provided an immediate closure, the histopathology raised concerns regarding the risk of perforation. Together with the high risk of intraabdominal infection, TG pure-NOTES is not yet ready for routine clinical practice.
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Affiliation(s)
- Anders Meller Donatsky
- Department of Surgical Gastroenterology, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, 2730 Herlev, Denmark.
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Soweid A, Yaghi S, Kobeissy A, El Majzoub N, Khreiss M, Alaeddine M, Ayoub C, Seoud M, Matar G, Jamali F. Natural orifice transluminal endoscopic surgery (NOTES): assessment of peritoneal bacterial load after intraperitoneal antimicrobial wash and evaluation of hemodynamic changes in a porcine model. MINIM INVASIV THER 2011; 21:265-70. [PMID: 21919809 DOI: 10.3109/13645706.2011.607828] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
Abstract
AIMS Natural orifice transluminal endoscopic surgery (NOTES) is a promising newly developed procedure; however, it is associated with many complications. The main aim of our study is to assess whether peritoneal wash with antibiotics decreases the bacterial load contamination related to the transgastric approach. METHODS Ten female farm pigs underwent transgastric peritoneoscopy with fallopian tubal ligation. Five pigs were randomized to antibiotic wash of the peritoneal cavity and five to placebo. All animals were given one intravenous dose of antibiotic before the procedure. Hemodynamic variables were continuously monitored throughout the procedure. The next day, peritoneal cultures were taken. The fallopian tubes were inspected to determine the success of ligation and the gastric incision sites were assessed for leakage. RESULTS No significant difference was noted between the antibiotic peritoneal wash group and the placebo group in terms of peritoneal bacterial load with respective median colony-forming units per ml (CFU/ml) of 0 [0; 1] vs. 0 [0; 4], p = 0.637. No clinically significant hemodynamic changes were noted during the procedure. CONCLUSIONS The results of our study indicate that NOTES carries minimal risk of peritoneal bacterial contamination, regardless of the use of intraperitoneal antibiotics, and is not associated with hemodynamic compromise.
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Affiliation(s)
- Assaad Soweid
- Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
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Guarner-Argente C, Córdova H, Martínez-Pallí G, Navarro-Ripoll R, Rodríguez-d’Jesús A, Miguel CRD, Beltrán M, Fernández-Esparrach G. Gastrotomy closure with a new tissue anchoring device: A porcine survival study. World J Gastroenterol 2011; 17:1732-8. [PMID: 21483634 PMCID: PMC3072638 DOI: 10.3748/wjg.v17.i13.1732] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/09/2010] [Revised: 12/01/2010] [Accepted: 12/08/2010] [Indexed: 02/06/2023] Open
Abstract
AIM: To evaluate the feasibility, reproducibility and efficacy of a new tissue anchoring device in a porcine survival model.
METHODS: Gastrotomies were performed using a needle-knife and balloon dilator in 10 female Yorkshire pigs weighing 30-35 kg. Gastric closure was attempted using a new tissue anchoring device. The tightness of the closure was confirmed by means of air insufflation and the ability to maintain gastric distension with stability in peritoneal pressure measured with a Veress needle. All animals were monitored daily for signs of peritonitis and sepsis over 14 d. During necropsy, the peritoneal cavity and the gastric access site were examined.
RESULTS: Transgastric access, closure and 14 d survival was achieved in all pigs. The mean closure time was 18.1 ± 19.2 min and a mean of 2.1 ± 1 devices were used. Supplementary clips were necessary in 2 cases. The closure time was progressively reduced (24.8 ± 13.9 min in the first 5 pigs vs 11.4 ± 5.9 min in the last 5, P = NS). At necropsy, the gastric access site was correctly closed in all cases with all brace-bars present. One device was misplaced in the mesocolon. Minimal adhesions were observed in 3 pigs and signs of mild peritonitis and adhesions in one.
CONCLUSIONS: The use of this new tissue anchoring device in porcine stomachs is feasible, reproducible and effective and requires a short learning curve.
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Kirschniak A, Subotova N, Zieker D, Königsrainer A, Kratt T. The Over-The-Scope Clip (OTSC) for the treatment of gastrointestinal bleeding, perforations, and fistulas. Surg Endosc 2011; 25:2901-5. [DOI: 10.1007/s00464-011-1640-2] [Citation(s) in RCA: 193] [Impact Index Per Article: 13.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/20/2010] [Accepted: 02/14/2011] [Indexed: 12/13/2022]
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von Renteln D, Denzer UW, Schachschal G, Anders M, Groth S, Rösch T. Endoscopic closure of GI fistulae by using an over-the-scope clip (with videos). Gastrointest Endosc 2010; 72:1289-1296. [PMID: 20951989 DOI: 10.1016/j.gie.2010.07.033] [Citation(s) in RCA: 77] [Impact Index Per Article: 5.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/17/2010] [Accepted: 07/22/2010] [Indexed: 02/08/2023]
Abstract
BACKGROUND Preclinical studies have demonstrated the over-the-scope clip (OTSC) to be feasible and safe for closure of gastric, duodenal, and colonic perforations. A retrospective clinical study demonstrated the feasibility and preliminary safety of the OTSC for the treatment of GI bleeding and closure of acute GI perforations. OBJECTIVE Because the OTSC allows rapid and easy endoscopic organ wall closure, we hypothesized that it might be a useful tool to close GI fistulae. DESIGN Case series. SETTING Academic medical center. PATIENTS Four consecutive patients with GI fistulae. INTERVENTIONS In all patients, a 12-mm OTSC, in combination with the dedicated twin grasper, anchor device, or endoscopic suction, was used to facilitate endoscopic closure. MAIN OUTCOME MEASUREMENTS In 2 cases, OTSCs allowed complete closure of a posttraumatic esophagopulmonary fistula and a chronic gastrocutaneous fistula. Leak tests and follow-up examination demonstrated complete leakproof closures. In 1 esophagopulmonary fistula and 1 jejunocutaneous fistula, the initial closure attempts using OTSCs were not successful because of chronic fibrotic changes and scarring at the fistula site. Both OTSCs were removed by using an endoscopic grasping forceps. The mean procedure time was 54 minutes (range 24-93 minutes). There were no procedure-related complications. LIMITATIONS Small sample size. CONCLUSIONS The OTSC seems to be a feasible device to close chronic fistulae of the GI tract. It can achieve leakproof, full-thickness closure of transmural defects. Nevertheless, in circumstances of severe fibrosis and scarring, complete incorporation of the defect into the applicator cap and successful OTSC application might not be possible.
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Affiliation(s)
- Daniel von Renteln
- Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany
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Endoscopic management of GI perforations with a new over-the-scope clip device (with videos). Gastrointest Endosc 2010; 72:881-6. [PMID: 20646699 DOI: 10.1016/j.gie.2010.04.006] [Citation(s) in RCA: 145] [Impact Index Per Article: 9.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/24/2009] [Accepted: 04/05/2010] [Indexed: 02/08/2023]
Abstract
BACKGROUND Through-the-scope endoclips have been used to manage small perforations in the GI tract, but they have limitations. A new over-the-scope clip system, OTSC (Ovesco Endoscopy, Tuebingen, Germany), may be suitable for the closure of larger GI leaks. OBJECTIVE To evaluate the clinical outcomes of patients with GI perforations of up to 20 mm, treated with OTSC. DESIGN Prospective, single-arm, pilot study. SETTING General hospitals referral centers for endotherapy. PATIENTS This study involved 10 patients (median age 58.5 years [range 27-82 years], 7 men) with GI leaks from perforations, fistulas, and anastomotic dehiscence. Two gastric, 2 duodenal, and 6 colonic leaks were treated with OTSC. The diameter of leaks ranged between 7 and 20 mm. INTERVENTIONS OTSC devices were used to seal the GI leaks. Then Gastrografin (Bayer AG, Germany) was introduced via the endoscope and complete sealing confirmed under fluoroscopy. Patients underwent a second endoscopic examination 3 months later. MAIN OUTCOME MEASUREMENT Complete sealing of the leak. RESULTS Complete sealing of leaks was achieved by using OTSC alone in 8 of 10 patients. For one patient, successful endoscopic management was completed by placing two additional covered stents. Only one patient required surgical repair of the leak. Endoscopic examination 3 months after treatment confirmed that leaks in 8 of 9 endoscopically treated patients were healed, and the patients did not have recurrence of the leaks or complications from the OTSC devices. One patient died from neoplastic progression before the second endoscopy could be performed. LIMITATIONS Uncontrolled study. CONCLUSIONS The OTSC system appears to be a useful device in the management of larger GI leaks in a variety of clinical scenarios.
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Abstract
PURPOSE OF REVIEW Since its introduction in 2000, natural orifice translumenal endoscopic surgery (NOTES) has gained a great deal of attention from gastroenterologists and surgeons all over the world. In this article, we will review the progress in the field of NOTES and present the latest publications that provide some answers and solutions to the barriers suggested by the Natural Orifice Surgery Consortium for Assessment and Research white paper. RECENT FINDINGS Because of the first human NOTES procedure by Rao and Reddy, more pioneering procedures, including transgastric and transvaginal cholecystectomies, appendectomies, and hernia repairs, have been performed. Although NOTES researchers continue to experiment with new innovative equipment and procedures in the lab, more structured work, including randomized controlled trials, has been published. SUMMARY In the last several years, there has been growing interest in NOTES, which has translated into exciting animal research work and publication of randomized controlled trials. Additionally, preliminary NOTES human procedures have been successfully performed. When suitable instruments become available, the subsequent step should be comparing NOTES with current laparoscopic approaches. Superiority or even equality of NOTES to laparoscopic surgery would be the best argument for advancing and integrating implementation into clinical practice.
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