Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

Not Applicable

Completed

• Conditions: Colonic Polyps
• Interventions: Device: Endoscopic Clip

• Registration Number: NCT02196649
• Lead Sponsor: Professor Michael Bourke

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 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.

Study Timeline

• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-22
• Study Start: 2014-10
• Primary Completion: 2020-12-01
• Study Completion: 2021-03-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Can give informed consent to trial participation
• Lesion size greater than 20 mm
• Lesion proximal to and inclusive of mid transverse colon
• Laterally spreading or sessile polyp morphology

Exclusion Criteria

• Previous resection or attempted resection of lesion
• Clip deployed prior to the completion of the EMR
• Major intraprocedural bleeding not treatable by coagulation
• Endoscopic appearance of invasive malignancy
• Age less than 18 years
• Pregnancy
• Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
• Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior to procedure
• American Society of Anesthesiology (ASA) Grade IV-V

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic Clipping	Endoscopic Clip	Participants randomised to the arm will receive endoscopic clips to their defect following EMR.

Primary Outcome Measures

Name	Time	Method
Post-Procedural Bleeding	14 days	Clinically significant post colonic wide-field EMR bleeding (CSPEB)

Secondary Outcome Measures

Name	Time	Method
Safety success	18 months	Safety - admission rates, adverse outcomes, deaths Rate of initial technical success Duration of procedure Recurrence rate

Trial Locations

Locations (1)

Westmead Endoscopy Unit; 🇦🇺 Westmead, New South Wales, Australia