NCT03654209

Post-resection Treatment of Large Colon Polyps

Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation or Argon Plasma Coagulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Recurrence

Interventions

Type	Name	Description
DEVICE	Argon Plasma Coagulation	APC will be applied to the perimeter of the resection site
DEVICE	Snare Tip Soft Coagulation	STSC will be applied to the perimeter of the resection site

Timeline

• Start date: 2018-10-16
• Primary completion: 2022-12-14
• Completion: 2022-12-14
• First posted: 2018-08-31
• Last updated: 2024-01-05
• Results posted: 2024-01-05

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study