Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial (CuRB)

March 25, 2025 updated by: Professor Michael Bourke

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Endoscopy Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic Clipping
Participants randomised to the arm will receive endoscopic clips to their defect following EMR.
Device: Endoscopic Clip
No Intervention: No Endoscopic Clipping
These participants will receive standard of care practice only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Procedural Bleeding
Time Frame: 14 days
Clinically significant post colonic wide-field EMR bleeding (CSPEB)
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety success
Time Frame: 18 months
Safety - admission rates, adverse outcomes, deaths Rate of initial technical success Duration of procedure Recurrence rate
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Michael Bourke

Investigators

  • Principal Investigator: Michael J Bourke, MBBS, Western Sydney Local Health District

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (Estimated)

July 22, 2014

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC2014/5/4.2(3971)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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