Post-resection Treatment of Large Colon Polyps
- Conditions
- Recurrence
- Interventions
- Device: Snare Tip Soft CoagulationDevice: Argon Plasma Coagulation
- Registration Number
- NCT03654209
- Lead Sponsor
- Indiana University
- Brief Summary
Patients who have provided informed consented and are scheduled to undergo endoscopic mucosal resection (EMR) of lesions 15mm and larger will be randomized to STSC (80 W, Effect 5) vs APC (preferred settings) vs No Treatment of the perimeter of the EMR site.
- Detailed Description
Data regarding polyp morphology, location \& shape will be recorded in addition to procedure and treatment length. Injection fluid use and clipping will also be recorded in addition to any procedural complications.
All randomized subjects will receive a 30-day post procedure follow-up phone call and be scheduled, as per the standard of care, to receive a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the rate of recurrence by endoscopic visualization of the EMR site at the first follow-up using endoscopic magnification and electronic chromoendoscopy, as well as systematic biopsy of the scars.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 384
- 25 years and older
- Ability to provide informed consent
- Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion
- Pedunculated lesions
- Inflammatory bowel disease
- Inability to provide informed consent
- Lesions less than 15mm in largest dimension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Snare Tip Soft Coagulation Snare Tip Soft Coagulation Following polyp removal using standard of care methods, Snare Tip Soft Coagulation (STSC) will be applied to the perimeter of the resection site before any clips are added. Argon Plasma Coagulation Argon Plasma Coagulation Following polyp removal using standard of care methods, Argon Plasma Coagulation (APC) will be applied to the perimeter of the resection site before any clips are added.
- Primary Outcome Measures
Name Time Method Types of Recurrences 1 day Description of whether recurrence was visible during the follow-up procedure and confirmed by pathology, visible during the follow-up procedure but not confirmed by pathology, or not visible during the follow-up procedure but confirmed by pathology of biopsies taken.
Recurrence 1 day The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy
- Secondary Outcome Measures
Name Time Method Time 1 day The time it takes to apply each respective treatment (APC or STSC) on the day of procedure
Complications 1 day To look at the number of complications for each randomization arm as assessed through a 30 day follow-up period
Trial Locations
- Locations (10)
Indiana University Health University Hospital
🇺🇸Indianapolis, Indiana, United States
Spring Mill Medical Center
🇺🇸Indianapolis, Indiana, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Penn State Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States