Clinical trial NCT02782793: Predictors of Unsuccessful Endoscopic Mucosal Resection of Complex Colon Polyps
Official title: Predictors of Unsuccessful Endoscopic Mucosal Resection of Complex Colon Polyps: "You Can Look But You Can't Touch"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Polyps
Keywords: Endoscopic
Mucosal
Resection
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: H. Lee Moffitt Cancer Center and Research Institute
name: University of California, Los Angeles
name: M.D. Anderson Cancer Center
First posted: 2016-05-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Endoscopic and clinical factors which predict failure of resection of large colon polyps
timeFrame: 5 year follow up
Secondary outcomes:
measure: Efficacy (%) of Endoscopic resection for large colon polyps
timeFrame: 5 year follow up
measure: Factors which predict recurrence of adenoma after large polyp resection
timeFrame: 5 year follow up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References: