Predictors of Unsuccessful Endoscopic Mucosal Resection of Complex Colon Polyps

Colon Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782793
• Other study ID #: STU00095441
• Status: Completed
• Phase: N/A
• First received: May 12, 2016
• Last updated: June 15, 2017
• Start date: August 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: June 2017
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Polyps
• Colonic Polyps
• Polyps

Intervention

Procedure:
• Endoscopic Mucosal Resection

Locations

Country	Name	City	State
United States	University of Colorado, Denver	Denver	Colorado
United States	MD Anderson Cancer Center	Houston	Texas
United States	UCLA Medical Center	Los Angeles	California
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy (%) of Endoscopic resection for large colon polyps		5 year follow up
Secondary	Factors which predict recurrence of adenoma after large polyp resection		5 year follow up