Post-resection Treatment of Large Colon Polyps (SAP)

Indiana University

Status: Completed

Conditions: Recurrence

Treatments: Device: Argon Plasma Coagulation; Device: Snare Tip Soft Coagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03654209

1805411306

Details and patient eligibility

About

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.

Full 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.

Enrollment: 384 patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 25 years and older
• Ability to provide informed consent
• Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion

Exclusion criteria

• Pedunculated lesions
• Inflammatory bowel disease
• Inability to provide informed consent
• Lesions less than 15mm in largest dimension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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384 participants in 3 patient groups

Argon Plasma Coagulation

Experimental group

Description:

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.

Treatment:

Device: Argon Plasma Coagulation

Snare Tip Soft Coagulation

Experimental group

Description:

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.

Treatment:

Device: Snare Tip Soft Coagulation

No treatment

No Intervention group

Description:

Following polyp removal using standard of care methods, neither APC nor STSC will be applied to the perimeter of the resection site. Clips may be added at the discretion of the PI.