Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

NCT ID: NCT02196649

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2021-03-01

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.

Conditions

Colonic Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Endoscopic Clipping

Participants randomised to the arm will receive endoscopic clips to their defect following EMR.

Group Type: EXPERIMENTAL

Endoscopic Clip

Intervention Type: DEVICE

No Endoscopic Clipping

These participants will receive standard of care practice only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Endoscopic Clip

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Professor Michael Bourke

OTHER

Sponsor Role: lead

Responsible Party

Professor Michael Bourke

Director of Gastrointestinal Endoscopy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael J Bourke, MBBS

Role: PRINCIPAL_INVESTIGATOR

Western Sydney Local Health District

Locations

Westmead Endoscopy Unit

Westmead, New South Wales, Australia

Countries

Australia

References

Gupta S, Sidhu M, Shahidi N, Vosko S, McKay O, Bahin FF, Zahid S, Whitfield A, Byth K, Brown G, Lee EYT, Williams SJ, Burgess NG, Bourke MJ. Effect of prophylactic endoscopic clip placement on clinically significant post-endoscopic mucosal resection bleeding in the right colon: a single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):152-160. doi: 10.1016/S2468-1253(21)00384-8. Epub 2021 Nov 18.

Reference Type: DERIVED

PMID: 34801133 (View on PubMed)

Other Identifiers

HREC2014/5/4.2(3971)

Identifier Type: -

Identifier Source: org_study_id