Study Results
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View full resultsBasic Information
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COMPLETED
NA
384 participants
INTERVENTIONAL
2018-10-16
2022-12-14
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Argon Plasma Coagulation
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.
Argon Plasma Coagulation
APC will be applied to the perimeter of the resection site
Snare Tip Soft Coagulation
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.
Snare Tip Soft Coagulation
STSC will be applied to the perimeter of the resection site
No treatment
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.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent
* Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion
Exclusion Criteria
* Inflammatory bowel disease
* Inability to provide informed consent
* Lesions less than 15mm in largest dimension
25 Years
ALL
Yes
Sponsors
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Erbe USA Incorporated
OTHER
Indiana University
OTHER
Responsible Party
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Douglas K. Rex
Principal Investigator
Principal Investigators
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Douglas K. Rex, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
AdventHealth Orlando
Orlando, Florida, 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
The Johns Hopkins Hospital
Baltimore, Maryland, 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
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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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.
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.
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.
Rex DK, Haber GB, Khashab M, Rastogi A, Hasan MK, DiMaio CJ, Kumta NA, Nagula S, Gordon S, Al-Kawas F, Waye JD, Razjouyan H, Dye CE, Moyer MT, Shultz J, Lahr RE, Yuen PYS, Dixon R, Boyd L, Pohl H. Snare Tip Soft Coagulation vs Argon Plasma Coagulation vs No Margin Treatment After Large Nonpedunculated Colorectal Polyp Resection: a Randomized Trial. Clin Gastroenterol Hepatol. 2024 Mar;22(3):552-561.e4. doi: 10.1016/j.cgh.2023.09.041. Epub 2023 Oct 21.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1805411306
Identifier Type: -
Identifier Source: org_study_id
NCT04063280
Identifier Type: -
Identifier Source: nct_alias
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