Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial
CuRB
Prophylactic and Endoscopic Clip Placement to Prevent Clinically Significant Post Wide Field Endoscopic Mucosal Resection Bleeding - a Randomised Controlled Trial.
1 other identifier
interventional
230
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2014
CompletedFirst Posted
Study publicly available on registry
July 22, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedMarch 27, 2025
March 1, 2025
6.2 years
July 17, 2014
March 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Post-Procedural Bleeding
Clinically significant post colonic wide-field EMR bleeding (CSPEB)
14 days
Secondary Outcomes (1)
Safety success
18 months
Study Arms (2)
Endoscopic Clipping
EXPERIMENTALParticipants randomised to the arm will receive endoscopic clips to their defect following EMR.
No Endoscopic Clipping
NO INTERVENTIONThese participants will receive standard of care practice only.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Westmead Endoscopy Unit
Westmead, New South Wales, 2145, Australia
Related Publications (1)
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.
PMID: 34801133DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Bourke, MBBS
Western Sydney Local Health District
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Gastrointestinal Endoscopy
Study Record Dates
First Submitted
July 17, 2014
First Posted
July 22, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2020
Study Completion
March 1, 2021
Last Updated
March 27, 2025
Record last verified: 2025-03