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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02196649
Other study ID # HREC2014/5/4.2(3971)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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