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NCT01368289 Clinical Trial

Australian Multicentre Colonic Endoscopic Mucosal Resection Study

Colonic Polyps Clinical Trial

— ACEEMR  

Official title:
Australian Multicentre Colonic Endoscopic Mucosal Resection (ACE/EMR) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01368289
Other study ID # ACE/EMR
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2008
Est. completion date September 2026

Study information
Verified date June 2023
Source Western Sydney Local Health District
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prospective, multicentre, observational study of all patients referred for endoscopic resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat analysis.

Description:

A prospective, multicentre, observational study of all patients referred for endoscopic resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat analysis. Detailed data regarding lesion characteristics (size, location, Paris classification, granular or non-granular surface morphology and Kudo pit pattern), procedural, clinical and histological outcomes and complications are noted. Multivariate analysis will be performed to identify risk factors for Endoscopic Mucosal Resection failure and adenoma recurrence at follow-up colonoscopy.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 3072
Est. completion date September 2026
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Large sessile polyp (equal to or greater than 20mm) - Intention to perform EMR - Aged 18 years or older Exclusion Criteria: - Colonic polyps less than 20mm - Aged younger then 18 years.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endoscopic Mucosal Resection
Endoscopic Mucosal Resection of large sessile colonic polyps.

Locations
Country Name City State
Australia Westmead Hospital 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 Technical success for Endoscopic resection To determine the safety, efficacy and predictors of success for Endoscopic Mucosal Resection of large sessile colorectal polyps. The utility of endoscopic criteria to stratify for the risk of Submucosal Invasive Cancer was also assessed. 6-60 months
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