title: Performance of the OTSC System in the endoscopic closure of iatrogenic gastrointestinal perforations: a systematic review.
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(®)).
  
  
  METHODS
  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.
authors: Novineon CRO, Tuebingen, Germany.
authors: Timo
authors: T
authors: Weiland
authors: Marion
authors: M
authors: Fehlker
authors: Thomas
authors: T
authors: Gottwald
authors: Marc O
authors: MO
authors: Schurr
mesh_terms: D000818:Animals; D020776:Endoscopes, Gastrointestinal; D016099:Endoscopy, Gastrointestinal / Q000295:instrumentation*; D004867:Equipment Design; D006801:Humans; D007049:Iatrogenic Disease; D007416:Intestinal Perforation / Q000601:surgery*; D013525:Surgical Instruments; D014945:Wound Healing