Status:
COMPLETED
Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial
Lead Sponsor:
Professor Michael Bourke
Conditions:
Colonic Polyps
Eligibility:
All Genders
18-99 years
Phase:
NA
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 standar...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT02196649
Start Date
October 1 2014
End Date
March 1 2021
Last Update
March 27 2025
Active Locations (1)
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1
Westmead Endoscopy Unit
Westmead, New South Wales, Australia, 2145