An over-the-scope clip (OTSC) system for closure of iatrogenic colon perforations: results of an experimental survival study in pigs

Abstract

Background and study aim: Perforation of the colon is a relatively rare complication of flexible endoscopy of the lower gastrointestinal tract. It has a reported incidence from between 0.2 % in diagnostic procedures to 0.5 % - 3 % in therapeutic procedures. Given the growing number of colonoscopies, the absolute number of iatrogenic perforations is not unimportant. The treatment of choice is most often surgical repair, since reliable and simple endoscopic techniques for perforation closure are currently unavailable. We aimed to evaluate our novel over-the-scope clip (OTSC) system for closure of iatrogenic perforations.

Material and methods: We have developed a nitinol clip that will capture perforations of 10 - 15 mm, compressing the lesions until healing. The OTSC was studied in a prospective experimental trial in pigs (50 - 60 kg, n=10) for the closure of an iatrogenic perforation of approximately 5 --10 mm on the serosal side, that was created by repeated endoscopic biopsy. The follow-up period was 12 weeks. Follow-up colonoscopy was performed at 4 and 12 weeks. Successful, tight closure of the lesion with absence of peritonitis in the postoperative course was the primary endpoint of the study.

Results: Nine animals had an uneventful clinical course. At termination of the study, macroscopic and microscopic examination of the clipping sites in the bowel wall showed normal tissue healing. One animal died 1 day postoperatively for reasons unrelated to the procedure.

Conclusions: In this experimental study the OTSC clip system was found to be a simple and secure closure method for iatrogenic colon perforations, and thus might be an alternative to surgical repair.