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Post-resection Treatment of Large Colon Polyps

Not Applicable
Completed
Conditions
Recurrence
Interventions
Device: Snare Tip Soft Coagulation
Device: 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
Inclusion Criteria
  • 25 years and older
  • Ability to provide informed consent
  • Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion
Read More
Exclusion Criteria
  • Pedunculated lesions
  • Inflammatory bowel disease
  • Inability to provide informed consent
  • Lesions less than 15mm in largest dimension
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Snare Tip Soft CoagulationSnare Tip Soft CoagulationFollowing 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 CoagulationArgon Plasma CoagulationFollowing 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
NameTimeMethod
Types of Recurrences1 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.

Recurrence1 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
NameTimeMethod
Time1 day

The time it takes to apply each respective treatment (APC or STSC) on the day of procedure

Complications1 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

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