Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

Colonic Polyps Clinical Trial

— CuRB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196649
• Other study ID #: HREC2014/5/4.2(3971)
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: March 1, 2021

Study information

• Verified date: June 2023
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: March 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyps

Intervention

Device:
• Endoscopic Clip

Locations

Country	Name	City	State
Australia	Westmead Endoscopy Unit	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Professor Michael Bourke

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Procedural Bleeding	Clinically significant post colonic wide-field EMR bleeding (CSPEB)	14 days
Secondary	Safety success	Safety - admission rates, adverse outcomes, deaths Rate of initial technical success Duration of procedure Recurrence rate	18 months