Clinical trial NCT03654209: Post-resection Treatment of Large Colon Polyps
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrence
Keywords: Argon Plasma Coagulation
Snare Tip Soft Coagulation
Recurrence rates
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Erbe USA Incorporated
First posted: 2018-08-31
Enrollment: 384
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to Argon Plasma Coagulation vs Snare Tip Soft Coagulation vs no treatment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence
timeFrame: 1 day
measure: Types of Recurrences
timeFrame: 1 day
Secondary outcomes:
measure: Time
timeFrame: 1 day
measure: Complications
timeFrame: 1 day
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Spring Mill Medical Center
state: Indiana
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Indiana University
name: Douglas K. Rex, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhan T, Hielscher T, Hahn F, Hauf C, Betge J, Ebert MP, Belle S. Risk Factors for Local Recurrence of Large, Flat Colorectal Polyps after Endoscopic Mucosal Resection. Digestion. 2016;93(4):311-7. doi: 10.1159/000446364. Epub 2016 Jun 7.
citation: Brooker JC, Saunders BP, Shah SG, Thapar CJ, Suzuki N, Williams CB. Treatment with argon plasma coagulation reduces recurrence after piecemeal resection of large sessile colonic polyps: a randomized trial and recommendations. Gastrointest Endosc. 2002 Mar;55(3):371-5. doi: 10.1067/mge.2002.121597.
citation: Tate DJ, Bahin FF, Desomer L, Sidhu M, Gupta V, Bourke MJ. Cold-forceps avulsion with adjuvant snare-tip soft coagulation (CAST) is an effective and safe strategy for the management of non-lifting large laterally spreading colonic lesions. Endoscopy. 2018 Jan;50(1):52-62. doi: 10.1055/s-0043-119215. Epub 2017 Oct 11.