Australian Multicentre Colonic Endoscopic Mucosal Resection Study (ACEEMR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Western Sydney Local Health District
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District
ClinicalTrials.gov Identifier:
NCT01368289
First received: June 6, 2011
Last updated: June 30, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


Further study details as provided by Western Sydney Local Health District:

Primary Outcome Measures:
  • Technical success for Endoscopic resection [ Time Frame: 6-60 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: 2000
Study Start Date: September 2008
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2018 (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368289

Contacts
Contact: Michael Bourke 0298459779 westmeadendoscopyresearch@gmail.com
Contact: Rebecca Sonson 0298459779 bec2153@gmail.com

Locations
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         
Sponsors and Collaborators
Professor Michael Bourke
Investigators
Principal Investigator: Michael Bourke Westmead Hospital - Endoscopy Unit
  More Information

No publications provided

Responsible Party: Professor Michael Bourke, 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: June 30, 2014
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Pathological Conditions, Anatomical
Polyps

ClinicalTrials.gov processed this record on October 22, 2014