NCT02196649

Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Professor Michael Bourke · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Colonic Polyps

Interventions

Type	Name	Description
DEVICE	Endoscopic Clip

Timeline

• Start date: 2014-10-01
• Primary completion: 2020-12-01
• Completion: 2021-03-01
• First posted: 2014-07-22
• Last updated: 2025-03-27

Locations

1 site across 1 country: Australia