Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colonic Polyps

Intervention / Treatment
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* Device: Endoscopic Clip


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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