Australian Multicentre Colonic Endoscopic Mucosal Resection Study (ACEEMR)

June 28, 2023 updated by: Professor Michael Bourke

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

3072

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Any patient who presents to the Unit with the intention to treat large sessile colonic polyps equal to or greater than 20mm.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Colonic Polyps
Patients who present with colonic polyps >20mm
Procedure: Endoscopic Mucosal Resection
Endoscopic Mucosal Resection of large sessile colonic polyps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success for Endoscopic resection
Time Frame: 6-60 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Michael Bourke

Investigators

  • Principal Investigator: Michael Bourke, Westmead Hospital - Endoscopy Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

November 1, 2016

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimated)

June 7, 2011

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACE/EMR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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