Prophylactic and Endoscopic Clip Placement to Prevent Clinically Significant Post Wide Field Endoscopic Mucosal Resection Bleeding - a Randomised Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colonic Polyps
- Sponsor
- Professor Michael Bourke
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Post-Procedural Bleeding
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Professor Michael Bourke
Director of Gastrointestinal Endoscopy
Western Sydney Local Health District
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
Outcomes
Primary Outcomes
Post-Procedural Bleeding
Time Frame: 14 days
Clinically significant post colonic wide-field EMR bleeding (CSPEB)
Secondary Outcomes
- Safety success(18 months)