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Australian Multicentre Colonic Endoscopic Mucosal Resection Study

Active, not recruiting
Conditions
Colonic Polyps
Interventions
Procedure: Endoscopic Mucosal Resection
Registration Number
NCT01368289
Lead Sponsor
Professor Michael Bourke
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.

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
3072
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Colonic PolypsEndoscopic Mucosal ResectionPatients who present with colonic polyps \>20mm
Primary Outcome Measures
NameTimeMethod
Technical success for Endoscopic resection6-60 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Westmead Hospital

🇦🇺

Westmead, New South Wales, Australia

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