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Completed

NCT Number: NCT02782793

Predictors of Unsuccessful Endoscopic Mucosal Resection of Complex Colon Polyps

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

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Key information

Conditions

Colon Polyps Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic mucosal resection

Procedure

Primary outcomes

  1. Endoscopic and clinical factors which predict failure of resection of large colon polyps

    Time frame: 5 year follow up

    A 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 outcomes

  1. Efficacy (%) of Endoscopic resection for large colon polyps

    Time frame: 5 year follow up

  2. Factors which predict recurrence of adenoma after large polyp resection

    Time frame: 5 year follow up

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 25, 2016
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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