Clinical Trial: Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prophylactic and Endoscopic Clip Placement to Prevent Clinically Significant Post Wide Field Endoscopic Mucosal Resection Bleeding - a Randomised Controlled Trial.

Brief Summary: Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal Resection (EMR) site following complete removal of the lesion, or will not receive clips and proceed with standard of care.

Detailed Summary: The outlined literature suggests that colonic post EMR bleeding may be prevented by the use of prophylactic endoscopic clips. There has thus far been no prospective study to confirm this concept. The ideal way to prove the hypothesis is to conduct a randomised controlled trial to evaluated the use of prophylactic clip placement on the EMR resection defect, for the purpose of preventing delayed bleeding in colonic wide field EMR (lesions>20mm). Given the significantly increased rate of bleeding in the proximal colon, clip placement in this location may have the greatest benefit. If it is proven that such a prophylactic technique is effective and safe, it may lead to significantly decreased patient morbidity and health care resources associated with the management delayed bleeding.
Sponsor: Professor Michael Bourke

Current Primary Outcome: Post-Procedural Bleeding [ Time Frame: 14 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety success [ Time Frame: 18 months ]

Original Secondary Outcome: Same as current

Information By: Western Sydney Local Health District

Dates:
Date Received: July 17, 2014
Date Started: October 2014
Date Completion: November 2019
Last Updated: August 13, 2016
Last Verified: August 2016