Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02196649

Acronym

CuRB

Enrollment

230

Registered

2014-07-22

Start date

2014-10-31

Completion date

2021-03-01

Last updated

2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyps

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.

Interventions

DEVICEEndoscopic Clip

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026