ACEEMR: Australian Multicentre Colonic Endoscopic Mucosal Resection Study

• Sponsor: Professor Michael Bourke (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01368289
• Collaborator: (none)
• Enrollment: 2,000
• Location: 1
• Duration (Months): 168
• Patients Per Site Per Month: 11.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyps	Procedure: Endoscopic Mucosal Resection

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 Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Australian Multicentre Colonic Endoscopic Mucosal Resection (ACE/EMR) Study
• Study Start Date: Sep 1, 2008
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Technical success for Endoscopic resection [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Professor Michael Bourke

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Professor Michael Bourke, Dr Michael Bourke, Western Sydney Local Health District
• ClinicalTrials.gov Identifier: NCT01368289
• Other Study ID Numbers: ACE/EMR
• First Posted: Jun 7, 2011
• Last Update Posted: Mar 23, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Colonic Polyps

Study Results

No Results Posted as of Mar 23, 2021