CuRB: Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

Sponsor

Professor Michael Bourke (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02196649

Collaborator

(none)

230

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyps	Device: Endoscopic Clip	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endoscopic Clipping Participants randomised to the arm will receive endoscopic clips to their defect following EMR.	Device: Endoscopic Clip
No Intervention: No Endoscopic Clipping These participants will receive standard of care practice only.

Arm

Intervention/Treatment

Experimental: Endoscopic Clipping

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

Device: Endoscopic Clip

No Intervention: No Endoscopic Clipping

These participants will receive standard of care practice only.

Outcome Measures

Primary Outcome Measures

Post-Procedural Bleeding [14 days]
Clinically significant post colonic wide-field EMR bleeding (CSPEB)

Secondary Outcome Measures

Safety success [18 months]
Safety - admission rates, adverse outcomes, deaths Rate of initial technical success Duration of procedure Recurrence rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westmead Endoscopy Unit	Westmead	New South Wales	Australia	2145

Sponsors and Collaborators

Professor Michael Bourke

Investigators

Principal Investigator: Michael J Bourke, MBBS, Western Sydney Local Health District

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District

ClinicalTrials.gov Identifier:

NCT02196649

Other Study ID Numbers:

HREC2014/5/4.2(3971)

First Posted:

Jul 22, 2014

Last Update Posted:

Mar 24, 2021

Last Verified:

Mar 1, 2021

Additional relevant MeSH terms:

Colonic Polyps

Study Results

No Results Posted as of Mar 24, 2021