Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

N/ACompletedNCT02196649

Professor Michael Bourke230 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

230

Conditions

Colonic Polyps

Interventions

Endoscopic ClipDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Westmead Endoscopy Unit

Westmead, New South Wales, Australia

Outcomes

Primary Outcomes

Post-Procedural Bleeding

Clinically significant post colonic wide-field EMR bleeding (CSPEB)

Time frame: 14 days

Secondary Outcomes

Safety success

Safety - admission rates, adverse outcomes, deaths Rate of initial technical success Duration of procedure Recurrence rate

Time frame: 18 months

Data from ClinicalTrials.gov

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