Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial (CuRB)

Professor Michael Bourke

Status: Completed

Conditions: Colonic Polyps

Treatments: Device: Endoscopic Clip

Study type: Interventional

Funder types: Other

Identifiers

NCT02196649

HREC2014/5/4.2(3971)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Endoscopic Clipping

Experimental group

Description:

Participants randomised to the arm will receive endoscopic clips to their defect following EMR.

Treatment:

Device: Endoscopic Clip

No Endoscopic Clipping

No Intervention group

Description:

These participants will receive standard of care practice only.