International multicenter experience with an over-the-scope clipping device for endoscopic management of GI defects (with video)

doi:10.1016/j.gie.2014.03.049

Gastrointestinal Endoscopy

Volume 80, Issue 4, October 2014, Pages 610-622

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https://doi.org/10.1016/j.gie.2014.03.049 Get rights and content

Background

The over-the-scope clip (OTSC) provides more durable and full-thickness closure as compared with standard clips. Only case reports and small case series have reported on outcomes of OTSC closure of GI defects.

Objective

To describe a large, multicenter experience with OTSCs for the management of GI defects. Secondary goals were to determine success rate by type of defect and type of therapy and to determine predictors of treatment outcomes.

Design

Multicenter, retrospective study.

Setting

Multiple, international, academic centers.

Patients

Consecutive patients who underwent attempted OTSC placement for GI defects, either as a primary or as a rescue therapy.

Interventions

OTSC placement to attempt closure of GI defects.

Main Outcome Measurements

Long-term success of the procedure.

Results

A total of 188 patients (108 fistulae, 48 perforations, 32 leaks) were included. Long-term success was achieved in 60.2% of patients during a median follow-up of 146 days. Rate of successful closure of perforations (90%) and leaks (73.3%) was significantly higher than that of fistulae (42.9%) (P < .05). Long-term success was significantly higher when OTSCs were applied as primary therapy (primary 69.1% vs rescue 46.9%; P = .004). On multivariate analysis, patients who had OTSC placement for perforations and leaks had significantly higher long-term success compared with those who had fistulae (OR 51.4 and 8.36, respectively).

Limitations

Retrospective design and multiple operators with variable expertise with the OTSC device.

Conclusion

OTSC is safe and effective therapy for closure of GI defects. Clinical success is best achieved in patients undergoing closure of perforations or leaks when OTSC is used for primary or rescue therapy. Type of defect is the best predictor of successful long-term closure.

Section snippets

Methods

This study was approved by the institutional review board for human research at each institution. The study complied with Health Insurance Portability and Accountability Act regulations (Office for Civil Rights. Standards for privacy of individually identifiable health information; final rule. August 14, 2002. 45 CFR parts 160 and 164.) at the 8 U.S. centers.

A retrospective review of consecutive patients who underwent attempted OTSC placement for the indication of GI leak, fistula, or

Results

During the study period, 188 patients (101 female, mean [± SD] age 58.7 ± 14.9 years) underwent OTSC placement for closure of GI defects. The most common indication for OTSC placement was closure of fistulae (108 patients [57.5%]), followed by perforations (48 patients [25.5%]), followed by leaks (32 patients [17.0%]. OTSCs were most commonly placed in the upper GI tract (esophagus and stomach, n = 118, 62.8%) followed by colon and rectum (n = 50, 26.6%) and the small bowel (n = 20, 10.6%) (

Discussion

One of the major challenges of current endoscopic practice is lack of a reliable and durable closure device for treatment of GI defects. Such a device will not only result in avoidance of more invasive approaches for the treatment of various pathologies (eg, acute perforations, anastomotic leaks, and fistulae) but will permit endoscopists to extend new treatment approaches to other GI diseases (eg, full-thickness resection of subepithelial lesions and natural orifice transluminal endoscopic

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: DISCLOSURE: M. Khashab is a consultant for Boston Scientific and Olympus America and received research funding from Cook Medical. J.-W. Poley is a consultant for Cook Medical and Boston Scientific. C. Thompson is a consultant for Apollo Endosurgery. E. Goldberg is a consultant for Olympus America and Boston Scientific. D. Schembre has a royalty agreement with and is on the speakers' bureau for Cook Medical and is a consultant for Boston Scientific. M. Hasan is a consultant for Boston Scientific. S. Varadarajulu is a consultant for Boston Scientific and Olympus America. R. Hawes is a consultant for Boston Scientific, Cook Medical, and Olympus America. All other authors disclosed no financial relationships relevant to this publication.

: See CME section; p. 679.

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Original articleClinical endoscopyInternational multicenter experience with an over-the-scope clipping device for endoscopic management of GI defects (with video)

Background

Objective

Design

Setting

Patients

Interventions

Main Outcome Measurements

Results

Limitations

Conclusion

Section snippets

Methods

Results

Discussion

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J Gastrointest Surg

Gastrointest Endosc

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Original article
Clinical endoscopy
International multicenter experience with an over-the-scope clipping device for endoscopic management of GI defects (with video)