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Predictors of Unsuccessful Endoscopic Mucosal Resection of Complex Colon Polyps

Predictors of Unsuccessful Endoscopic Mucosal Resection of Complex Colon Polyps: You Can Look But You Can't Touch

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02782793
Enrollment
500
Registered
2016-05-25
Start date
2014-08-31
Completion date
2016-12-31
Last updated
2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Polyps

Keywords

Endoscopic, Mucosal, Resection

Brief summary

A prospective outcomes study in patients referred for endoscopic mucosal resection of complex colon polyps.

Detailed description

Colon cancer is the third leading cause of cancer-related death in the United States. The number of these deaths has significantly decreased due to screening colonoscopies. A colonoscopy is a procedure in which a physician examines the rectum and large intestines for abnormalities through the use of a specialized camera called an endoscope. Colonoscopies decrease the mortality associated with colon cancer through two main ways: by detecting and removing pre-cancerous lesions called polyps; and by detecting colon cancer at earlier stage, when therapies can still be effective at treating or removing the cancer. Most colon polyps are small and can be completely removed during a standard colonoscopy. However, there is a growing awareness amongst endoscopists of polyps that are too large or inaccessible to be safely removed during a routine colonoscopy. Previously, these lesions required surgery for removal of the affected part of the colon. There is a growing body of evidence that suggests these more complex colon polyps can be entirely removed endoscopically through a procedure called endoscopic mucosal resection (EMR), thereby avoiding costly and debilitating surgery. Given that it is a novel procedure, it is only available at specialized care centers. EMR is a procedure identical to a colonoscopy, with more steps involved in the lifting and removal of complex polyps. As many as 80-90% of complex polyps can be successfully removed with EMR. However, it has been noted that removal of the polyp in pieces, rather than as a whole can result in a 20-30% recurrence rate at the resection site. Any manipulation of the polyp prior to EMR may impair the ability to fully remove the lesion. Some factors that have previously been suggested to increase the difficulty of EMR include previous dye injections, removal attempts, and polyp sampling. However, the true impact of previous manipulations of CCPs remains unclear. This study aims to be one of the largest prospective, multi-centered studies investigating factors that predict the failure of EMR in the removal of complex colon polyps.

Interventions

PROCEDUREEndoscopic Mucosal Resection

Sponsors

University of Colorado, Denver
CollaboratorOTHER
H. Lee Moffitt Cancer Center and Research Institute
CollaboratorOTHER
University of California, Los Angeles
CollaboratorOTHER
M.D. Anderson Cancer Center
CollaboratorOTHER
Northwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* All patients referred to each of the participating tertiary care centers for endoscopic mucosal resection (EMR)

Exclusion criteria

* Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Endoscopic and clinical factors which predict failure of resection of large colon polyps5 year follow upA systematic, prospective collection of data from a large cohorts of patients referred for colon EMR will provide useful data in effort to improve overall patient outcomes.

Secondary

MeasureTime frame
Efficacy (%) of Endoscopic resection for large colon polyps5 year follow up
Factors which predict recurrence of adenoma after large polyp resection5 year follow up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026