Australian Multicentre Colonic Endoscopic Mucosal Resection Study (ACEEMR)
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Purpose
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 | Intervention |
|---|---|
|
Colonic Polyps |
Procedure: Endoscopic Mucosal Resection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Australian Multicentre Colonic Endoscopic Mucosal Resection (ACE/EMR) Study |
- Technical success for Endoscopic resection [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 1000 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Colonic Polyps
Patients who present with colonic polyps >20mm
|
Procedure: Endoscopic Mucosal Resection
Endoscopic Mucosal Resection of large sessile colonic polyps.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Any patient who presents to the Unit with the intention to treat large sessile colonic polyps equal to or greater than 20mm.
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| Contact: Michael Bourke | 0298459779 | westmeadendoscopyresearch@gmail.com |
| Contact: Rebecca Sonson | 0298459779 | bec2153@gmail.com |
| Australia, New South Wales | |
| Westmead Hospital | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Contact: Michael J Bourke 0298459779 westmeadendoscopyresearch@gmail.com | |
| Contact: Rebecca Sonson 0298459779 bec2153@gmail.com | |
| Principal Investigator: Michael Bourke | |
| Principal Investigator: Alan Moss | |
| Sub-Investigator: Stephen Willia | |
| Principal Investigator: | Michael Bourke | Westmead Hospital - Endoscopy Unit |
More Information
No publications provided
| Responsible Party: | Dr Michael Bourke, Western Sydney Local Health District |
| ClinicalTrials.gov Identifier: | NCT01368289 History of Changes |
| Other Study ID Numbers: | ACE/EMR |
| Study First Received: | June 6, 2011 |
| Last Updated: | November 27, 2012 |
| Health Authority: | Australia: Human Research Ethics Committee |
Additional relevant MeSH terms:
|
Colonic Polyps Intestinal Polyps Polyps Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013