Post-resection Treatment of Large Colon Polyps

Recurrence Clinical Trial

— SAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654209
• Other study ID #: 1805411306
• Status: Completed
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: December 14, 2022

Study information

• Verified date: January 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT04063280

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Recurrence

Intervention

Device:
• Argon Plasma Coagulation
APC will be applied to the perimeter of the resection site
• Snare Tip Soft Coagulation
STSC will be applied to the perimeter of the resection site

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	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	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	NYU Langone Medical Center	New York	New York
United States	The Mount Sinai Hospital	New York	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Erbe USA Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy	1 day
Primary	Types of Recurrences	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.	1 day
Secondary	Time	The time it takes to apply each respective treatment (APC or STSC) on the day of procedure	1 day
Secondary	Complications	To look at the number of complications for each randomization arm as assessed through a 30 day follow-up period	1 day