Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR). The CLIPPER Study: A Nationwide Multi-center Randomized Clinical Trail

Design

This is a multi-center, randomized, patient-blinded multicenter trial, comparing two treatment strategies in 356 patients undergoing EMR for a colonic lesion 2-6 cm. The study will be enrolled in a selection of academic and non-academic Dutch hospitals. Patients undergoing an EMR will be a randomly allocated by web-based randomization to:

A) PC treatment group: minimally 1 clip per 1 cm of the polyp resection plane: OR B) Control group: standard care: only clip placement in case of uncontrollable bleeding (not successfully managed by coagulation) AND/OR perforation.

Population The target population in this proposal includes patients of 18 years and older, who gave written informed consent, undergoing EMR of a colonic polyp with a moderate to severe risk of developing DB. Moderate-severe risk of DB is defined as a laterally spreading or sessile polyp morphology proximal to the splenic flexure, measuring 2-6cm. Given the significantly increased risk of bleeding in the cecum, ascending and transverse colon, clip placement at this location may have the greatest benefit.

Inclusion Gastroenterologists from participating hospitals of the Dutch EMR Study Group will be asked to recruit patients for the trial. They will provide written information about the trial to potential participants, i.e., all patients scheduled for an EMR of a (right-sided) colonic polyp 2-6 cm, and 18 years or older. Members of the study group will contact potentially eligible patients at the outpatient clinic, hospital wards or by phone and give detailed information about the trial. In- and exclusion criteria will be checked and questions about the trial will be answered. Eligible patients will be invited to participate. After both the patient and the study physician or nurse practitioner have signed the informed consent form, in- and exclusion criteria will be checked again and baseline measurements will be performed, which include disease specific questionnaires including risk-factors for DB (AC use, restarting AC, polyp size, visible vessel, etc) and generic and disease specific quality of life questionnaires (see below). Patient's contact details will be provided to the study center for randomization.