Multicenter randomized controlled study to assess the effect of prophylactic clipping on post-polypectomy delayed bleeding

Abstract

Background

Prophylactic clipping has been widely used to prevent post-polypectomy bleeding. However, its efficiency has not been confirmed and there is no consensus on the usefulness of prophylactic clipping.

Aim

To evaluate the preventive effect of prophylactic clipping on post-polypectomy bleeding.

Methods

A multicenter randomized controlled study was conducted from January 2012 to July 2013 in Japan. Patients who had polyps <2 cm were divided into a clipping group and non-clipping group by cluster randomization. After endoscopic polypectomy, patients allocated to the clipping group underwent prophylactic clipping, whereas the procedures was finished without clipping in patients allocated to the non-clipping group.. The occurrence of post-polypectomy bleeding was compared between the two groups.

Results

Seven hospitals participated in this study. A total of 3365 polyps in 1499 patients were evaluated. The clipping group consisted of 1636 polyps in 752 patients, and the non-clipping group consisted of 1729 polyps in 747 patients. Post-polypectomy bleeding occurred in 1.10% (18/1636) of the cases in the clipping group, and in 0.88% (15/1729) of those in the non-clipping group. The difference was -0.22% (95%CI: -0.96, 0.53). The upper limit of the 95%CI was lower than the non-inferiority margin (1.5%), and we could thus prove the non-inferiority of non-clipping against clipping.

Conclusion

Prophylactic clipping is not necessary to prevent post-polypectomy bleeding for polyps of less than 2 cm.

UMIN000007165

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