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Completed

NCT Number: NCT02196649

Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Clip

Device

Primary outcomes

  1. Post-Procedural Bleeding

    Time frame: 14 days

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

Secondary outcomes

  1. Safety success

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Professor Michael Bourke

Other

Registry information

Official study title

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

Acronym: CuRB

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Jul 22, 2014
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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