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Australian Multicentre Colonic Endoscopic Mucosal Resection Study (ACEEMR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01368289
Recruitment Status : Recruiting
First Posted : June 7, 2011
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368289


Contacts
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Contact: Michael Bourke 0298459779 westmeadendoscopyresearch@gmail.com
Contact: Kathleen Goodrick 0298459779 kathleen.goodrick@health.nsw.gov.au

Locations
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Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Michael J Bourke    0298459779    westmeadendoscopyresearch@gmail.com   
Principal Investigator: Michael Bourke         
Principal Investigator: Alan Moss         
Sub-Investigator: Stephen Willia         
Sponsors and Collaborators
Professor Michael Bourke
Investigators
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Principal Investigator: Michael Bourke Westmead Hospital - Endoscopy Unit
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: June 7, 2011    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical