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"

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

Study Overview

• Status: Completed
• Conditions: Colon Polyps
• Intervention / Treatment: Procedure: Endoscopic Mucosal Resection

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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
  • Colorado
    • Denver, Colorado, United States, 80202
      • University of Colorado, Denver
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Formation of a multi-site prospective database of patients refereed for endoscopic mucosal resection for a complex colon polyp(s).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient's with complex colon polyps	Procedure: Endoscopic Mucosal Resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic and clinical factors which predict failure of resection of large colon polyps	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.	5 year follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy (%) of Endoscopic resection for large colon polyps	5 year follow up
Factors which predict recurrence of adenoma after large polyp resection	5 year follow up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Resection; Endoscopic; Mucosal
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: STU00095441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No