Skip to main content

Advertisement

SpringerLink
Log in

Performance of the OTSC System in the endoscopic closure of iatrogenic gastrointestinal perforations: a systematic review

  • Review
  • Published:
Surgical Endoscopy Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Iqbal CW, Cullinane DC, Schiller HJ, Sawyer MD, Zietlow SP, Farley DR (2008) Surgical management and outcomes of 165 colonoscopic perforations from a single institution. Arch Surg 143:701–706

    Article  PubMed  Google Scholar 

  2. Lüning TH, Keemers-Gels ME, Barendregt WB, Tan AC, Rosman C (2007) Colonoscopic perforations: a review of 30, 366 patients. Surg Endosc 21:994–997

    Article  PubMed  Google Scholar 

  3. Kang HY, Kang HW, Kim SG, Kim JS, Park KJ, Jung HC, Song IS (2008) Incidence and management of colonoscopic perforations in Korea. Digestion 78:218–223

    Article  PubMed  Google Scholar 

  4. Araujo SE, Seid VE, Caravatto PP, Dumarco R (2009) Incidence and management of colonoscopic colon perforations: 10 years experience. Hepatogastroenterology 56:1633–1636

    PubMed  Google Scholar 

  5. Technology Committee ASGE, Kantsevoy SV, Adler DG, Conway JD, Diehl DL, Farraye FA, Kwon R, Mamula P, Rodriguez S, Shah RJ, Wong Kee Song LM, Tierney WM (2008) Endoscopic mucosal resection and endoscopic submucosal dissection. Gastrointest Endosc 68:11–18

    Article  Google Scholar 

  6. Arezzo A, Verra M, Reddavid R, Cravero F, Bonino MA, Morino M (2012) Efficacy of the over-the-scope clip (OTSC) for treatment of colorectal postsurgical leaks and fistulas. Surg Endosc 26:3330–3333. doi:10.1007/s00464-012-2340-2

    Article  PubMed  Google Scholar 

  7. Hayashi I, Yonezawa TM, Kuwabara T, Kudoh I (1975) The study on staunch clip for the treatment by endoscopy. Gastroenterol Endosc 17:92–101

    Google Scholar 

  8. Grupka MJ, Benson J (2008) Endoscopic clipping. J Dig Dis 9:72–78

    Article  PubMed  Google Scholar 

  9. Schurr MO, Hartmann C, Ho CN, Fleisch C, Kirschniak A (2008) An over-the-scope clip (OTSC) system for closure of iatrogenic colon perforations: results of an experimental survival study in pigs. Endoscopy 40:584–588

    Article  PubMed  CAS  Google Scholar 

  10. Borenstein M, Hedges L, Higgins JP, Rothstein HR (2009) Introduction to meta-analysis. Wiley, West Sussex

    Book  Google Scholar 

  11. Schurr MO, Hartmann C, Kirschniak A, Ho CN, Fleisch C, Buess G (2008) Experimental study on a new method for colonoscopic closure of large-bowel perforations with the OTSC clip. Biomed Technol (Berl) 53:45–51

    Article  Google Scholar 

  12. von Renteln D, Schmidt A, Vassiliou MC, Rudolph HU, Gieselmann M, Caca K (2009) Endoscopic closure of large colonic perforations using an over-the-scope clip: a randomized controlled porcine study. Endoscopy 41:481–486

    Article  Google Scholar 

  13. von Renteln D, Rudolph HU, Schmidt A, Vassiliou MC, Caca K (2010) Endoscopic closure of duodenal perforations by using an over-the-scope clip: a randomized, controlled porcine study. Gastrointest Endosc 71:131–138

    Article  Google Scholar 

  14. Zhang XL, Qu JH, Sun G, Tang P, Yang YS (2012) Feasibility study of secure closure of gastric fundus perforation using over-the-scope clips in a dog model. J Gastroenterol Hepatol 27:1200–1204

    Article  PubMed  Google Scholar 

  15. von Renteln D, Schmidt A, Vassiliou MC, Rudolph HU, Caca K (2010) Endoscopic full-thickness resection and defect closure in the colon. Gastrointest Endosc 71:1267–1273

    Article  Google Scholar 

  16. Schurr MO, Baur F, Ho CN, Anhoeck G, Kratt T, Gottwald T (2011) Endoluminal full-thickness resection of GI lesions: a new device and technique. Minim Invasive Ther Allied Technol 20:189–192

    Article  PubMed  Google Scholar 

  17. von Renteln D, Kratt T, Rösch T, Denzer UW, Schachschal G (2011) Endoscopic full-thickness resection in the colon by using a clip-and-cut technique: an animal study. Gastrointest Endosc 74:1108–1114

    Article  Google Scholar 

  18. von Renteln D, Rösch T, Kratt T, Denzer UW, El-Masry M, Schachschal G (2012) Endoscopic full-thickness resection of submucosal gastric tumors. Dig Dis Sci 57:1298–1303

    Article  CAS  Google Scholar 

  19. Kratt T, Küper M, Traub F, Ho CN, Schurr MO, Königsrainer A, Granderath FA, Kirschniak A (2008) Feasibility study for secure closure of natural orifice transluminal endoscopic surgery gastrotomies by using over-the-scope clips. Gastrointest Endosc 68:993–996

    Article  PubMed  Google Scholar 

  20. von Renteln D, Schmidt A, Vassiliou MC, Gieselmann M, Caca K (2009) Natural orifice transluminal endoscopic surgery gastrotomy closure with an over-the-endoscope clip: a randomized, controlled porcine study (with videos). Gastrointest Endosc 70:732–739

    Article  Google Scholar 

  21. von Renteln D, Vassiliou MC, Rothstein RI (2009) Randomized controlled trial comparing endoscopic clips and over-the-scope clips for closure of natural orifice transluminal endoscopic surgery gastrotomies. Endoscopy 41:1056–1061

    Article  Google Scholar 

  22. Donatsky AM, Andersen L, Nielsen OL, Holzknecht BJ, Vilmann P, Meisner S, Jørgensen LN, Rosenberg J (2012) 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 26:1952–1962

    Article  PubMed  Google Scholar 

  23. Voermans RP, van Berge Henegouwen MI, Bemelman WA, Fockens P (2011) Hybrid NOTES transgastric cholecystectomy with reliable gastric closure: an animal survival study. Surg Endosc 25:728–736

    Article  PubMed  Google Scholar 

  24. Arezzo A, Kratt T, Schurr MO, Morino M (2009) Laparoscopic-assisted transgastric cholecystectomy and secure endoscopic closure of the transgastric defect in a survival porcine model. Endoscopy 41:767–772

    Article  PubMed  CAS  Google Scholar 

  25. Rolanda C, Lima E, Silva D, Moreira I, Pêgo JM, Macedo G, Correia-Pinto J (2009) In vivo assessment of gastrotomy closure with over-the-scope clips in an experimental model for varicocelectomy (with video). Gastrointest Endosc 70:1137–1145

    Article  PubMed  Google Scholar 

  26. Pătraşcu S, Surlin V, Râmboiu S, Georgescu E (2011) Histological evaluation of pure NOTES: related complications in a survival animal study. Rom J Morphol Embryol 52:867–871

    PubMed  Google Scholar 

  27. Bernhardt J, Köhler P, Rieber F, Diederich M, Schneider-Koriath S, Steffen H, Ludwig K, Lamadé W (2012) Pure NOTES sigmoid resection in an animal survival model. Endoscopy 44:265–269

    Article  PubMed  CAS  Google Scholar 

  28. Hucl T, Kocik M, Benes M, Krak M, Maluskova J, Kieslichova E, Oliverius M, Spicak J (2011) NOTES assisted minilaparoscopic transgastric cholecystectomy. Abstract P1108 UEWG Stockholm 2011

  29. Hucl T, Kocik M, Benes M, Krak M, Maluskova J, Kieslichova E, Oliverius M, Spicak J (2011) Over-the-scope-clip closure of gastric and colonic access in NOTES endoscopic surgery. Abstract OP 204 UEWG Stockholm 2011

  30. Suhail AH, Mårvik R, Halgunset J, Kuhry E (2012) 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 25:2773–2843. doi:10.1007/s00464-012-2290-8

    Google Scholar 

  31. Armengol J, Bertroli Abu-Suboh, Abadia M, Dot Bach J, Masachs Peracaula M, Benages Curell A, Salord Oses JC, Kantsevoy S, Armengol Miro JR (2010) Comparison of different over-the-scope devices for gastric incision closure post NOTES procedures. ESGE Newsletter. Endoscopy 42:775–779

    Article  Google Scholar 

  32. Azadani A, Bergström M, Dot J, Abu-Suboh-Abadia M, Armengol-Miró JR, Park PO (2012) 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 22:46–50

    Article  PubMed  Google Scholar 

  33. Voermans RP, Le Moine O, von Renteln D, Ponchon T, Giovannini M, Bruno M, Weusten B, Seewald S, Costamagna G, Deprez P, Fockens P, CLIPPER Study Group (2012) Efficacy of endoscopic closure of acute perforations of the gastrointestinal tract. Clin Gastroenterol Hepatol 10:603–608

    Article  PubMed  Google Scholar 

  34. Gubler C, Bauerfeind P (2012) Endoscopic closure of iatrogenic gastrointestinal tract perforations with the over-the-scope clip. Digestion 85:302–307

    Article  PubMed  Google Scholar 

  35. Schlag C, von Delius S, Feussner H, Wilhelm D, Beitz A, Schmid RM, Meining A (2011) Endoscopic full-thickness resection of gastric subepithelial masses: a step towards NOTES? Abstract P 1080 UEWG Stockholm 2011

  36. Parodi A, Repici A, Pedroni A, Blanchi S, Conio M (2010) Endoscopic management of GI perforations with a new over-the-scope clip device (with videos). Gastrointest Endosc 72:881–886

    Article  PubMed  Google Scholar 

  37. Baron TH, Wong Kee Song LM, Ross A, Tokar JL, Irani S, Kozarek RA (2012) Use of an over-the-scope clipping device: multicenter retrospective results of the first U.S. experience (with videos). Gastrointest Endosc 76:202–228

    Article  PubMed  Google Scholar 

  38. Albert JG, Friedrich-Rust M, Woeste G, Strey C, Bechstein WO, Zeuzem S, Sarrazin C (2011) Benefit of a clipping device in use in intestinal bleeding and intestinal leakage. Gastrointest Endosc 74:389–397

    Article  PubMed  Google Scholar 

  39. Manta R, Manno M, Bertani H, Barbera C, Pigò F, Mirante V, Longinotti E, Bassotti G, Conigliaro R (2011) Endoscopic treatment of gastrointestinal fistulas using an over-the-scope clip (OTSC) device: case series from a tertiary referral center. Endoscopy 43:545–548

    Article  PubMed  CAS  Google Scholar 

  40. Hagel A, Nägel A, Lindner A, Kessler H, Matzel K, Diebel H, Raithel S, Neurath M, Raithel M (2012) Over-the-scope-clip–applikation ermöglicht eine hohe Verschlussrate bei verschiedenen Arten von gastrointestinalen Perforationen. Endo heute 25:83

    Google Scholar 

  41. Dişibeyaz S, Köksal AS, Parlak E, Torun S, Saşmaz N (2012) Endoscopic closure of gastrointestinal defects with an over-the-scope clip device. A case series and review of the literature. Clin Res Hepatol Gastroenterol 36:614–621. doi:10.1016/j.clinre.2012.04.015

    Article  PubMed  Google Scholar 

  42. Kirschniak A, Kratt T, Stüker D, Braun A, Schurr MO, Königsrainer A (2007) A new endoscopic over-the-scope clip system for treatment of lesions and bleeding in the GI tract: first clinical experiences. Gastrointest Endosc 66:162–167

    Article  PubMed  Google Scholar 

  43. Kirschniak A, Subotova N, Zieker D, Königsrainer A, Kratt T (2011) The Over-The-Scope Clip (OTSC) for the treatment of gastrointestinal bleeding, perforations, and fistulas. Surg Endosc 25:2901–2905

    Article  PubMed  Google Scholar 

  44. Seebach L, Bauerfeind P, Gubler C (2010) “Sparing the surgeon”: clinical experience with over-the-scope clips for gastrointestinal perforation. Endoscopy 42:1108–1111

    Article  PubMed  CAS  Google Scholar 

  45. Sandmann M, Heike M, Faehndrich M (2011) Application of the OTSC system for the closure of fistulas, anastomosal leakages and perforations within the gastrointestinal tract. Z Gastroenterol 49:981–985

    Article  PubMed  CAS  Google Scholar 

  46. Sandmann M, Heike M, Fähndrich M (2012) Neue Einsatzmöglichkeiten des OTSC-systems im gastrointestinaltrakt–ergebnisse und verläufe nach 2 jahren praktischer erfahrung. Endo heute 25:67

    Article  Google Scholar 

  47. Wedi E, Menke D, Hochberger J (2012) Der over-the-scope-clip (otsc)–erste klinische erfahrungen bei der behandlung von schweren blutungen, perforationen und fisteln an 40 patienten. Endo heute 25:69

    Article  Google Scholar 

  48. Vijverman A, Piessevaux H, Aouattah T, Gigot JF, Deprez PH (2011) Better outcome of endoscopic management vs surgery for upper gastrointestinal perforation. Abstract OP 447 UEWG Stockholm 2011

  49. Trecca A, Gaj F, Gagliardi G (2008) Our experience with endoscopic repair of large colonoscopic perforations and review of the literature. Tech Coloproctol 12:315–321

    Article  PubMed  CAS  Google Scholar 

  50. Minami S, Gotoda T, Ono H, Oda I, Hamanaka H (2006) Complete endoscopic closure of gastric perforation induced by endoscopic resection of early gastric cancer using endoclips can prevent surgery (with video). Gastrointest Endosc 63:596–601

    Article  PubMed  Google Scholar 

  51. Merrifield BF, Wagh MS, Thompson CC (2006) Peroral transgastric organ resection: a feasibility study in pigs. Gastrointest Endosc 63:693–697

    Article  PubMed  Google Scholar 

  52. Rattner D, Kalloo A, ASGE/SAGES Working Group (2006) ASGE/SAGES working group on natural orifice translumenal endoscopic surgery. Surg Endosc 20:329–333

    Article  PubMed  CAS  Google Scholar 

  53. Meining A, Feussner H, Swain P, Yang GZ, Lehmann K, Zorron R, Meisner S, Ponsky J, Martiny H, Reddy N, Armengol-Miro JR, Fockens P, Fingerhut A, Costamagna G (2011) Natural-orifice transluminal endoscopic surgery (NOTES) in Europe: summary of the working group reports of the Euro-NOTES meeting 2010. Endoscopy 43:140–143

    Article  PubMed  CAS  Google Scholar 

  54. von Renteln D, Vassiliou MC, Rothstein RI (2010) Endoscopic removal of the Padlock-G Clip. Endoscopy 42(Suppl 2):E241–E242

    Article  Google Scholar 

  55. Guarner-Argente C, Córdova H, Martínez-Pallí G, Navarro R, Cuatrecasas M, Rodríguez de Miguel C, Beltrán M, Lacy AM, Ginès A, Pellisé M, Llach J, Fernández-Esparrach G (2010) Yes, we can: reliable colonic closure with the Padlock-G clip in a survival porcine study (with video). Gastrointest Endosc 72:841–844

    Article  PubMed  Google Scholar 

  56. Desilets DJ, Romanelli JR, Earle DB, Chapman CN (2010) Gastrotomy closure with the lock-it system and the Padlock-G clip: a survival study in a porcine model. J Laparoendosc Adv Surg Tech A 20:671–676

    Article  PubMed  Google Scholar 

  57. Cho SB, Lee WS, Joo YE, Kim HR, Park SW, Park CH, Kim HS, Choi SK, Rew JS (2012) Therapeutic options for iatrogenic colon perforation: feasibility of endoscopic clip closure and predictors of the need for early surgery. Surg Endosc 26:473–479

    Article  PubMed  Google Scholar 

  58. Jovanovic I, Zimmermann L, Fry LC, Mönkemüller K (2011) Feasibility of endoscopic closure of an iatrogenic colon perforation occurring during colonoscopy. Gastrointest Endosc 73:550–555

    Article  PubMed  Google Scholar 

  59. Seewald S, Soehendra N (2006) Perforation: part and parcel of endoscopic resection? Gastrointest Endosc 63:602–605

    Article  PubMed  Google Scholar 

  60. Fähndrich M, Sandmann M, Heike M (2011) Removal of over the scope clips (OTSC) with an Nd:YAG laser. Z Gastroenterol 49:579–583

    Article  PubMed  Google Scholar 

  61. Mangiavillano B, Morandi E, Masci E (2012) Accidental endoscopic piercing of the tongue with an Ovesco clip. Endoscopy 44(Suppl 2):E221

    PubMed  Google Scholar 

Download references

Disclosures

Timo Weiland and Marion Fehlker are employees of Novineon CRO, a contract research organization. Novineon CRO received funding from Ovesco Endoscopy AG to support this systematic literature study. Thomas Gottwald and Marc Schurr hold management positions with Ovesco Endoscopy AG. Timo Weiland, Marion Fehlker, Thomas Gottwald, and Marc O. Schurr have no conflicts of interest or financial ties to disclose.

Author information

Authors and Affiliations

  1. Novineon CRO, Tuebingen, Germany

    Timo Weiland & Marion Fehlker

  2. Medical Faculty, Eberhard-Karls University, Tuebingen, Germany

    Thomas Gottwald

  3. Steinbeis University Berlin, Dorfackerstrasse 26, 72074, Tuebingen, Germany

    Marc O. Schurr

  4. Ovesco Endoscopy AG, Tuebingen, Germany

    Thomas Gottwald & Marc O. Schurr

Authors
  1. Timo Weiland
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Marion Fehlker
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Thomas Gottwald
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Marc O. Schurr
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Marc O. Schurr.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Weiland, T., Fehlker, M., Gottwald, T. et al. Performance of the OTSC System in the endoscopic closure of iatrogenic gastrointestinal perforations: a systematic review. Surg Endosc 27, 2258–2274 (2013). https://doi.org/10.1007/s00464-012-2754-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00464-012-2754-x

Keywords

Search

Navigation