A Pilot Randomized Trial of Polypectomy Techniques for 4-6 mm Colonic Polyps

NCT04666194 | Completed DMC

• 1 other identifier: 1011004273/0801-16
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 3

Brief Summary

Complete polypectomy is one of the major factors for effectiveness of colonoscopy to prevent colon cancer. Given the prevalence of the 4-6 mm polyp, and the concern about interval cancers at polypectomy sites, there is a clear and significant need to determine which technique(s) are most appropriate for clinical practice. This study was to compare the three commonly used polypectomy techniques in terms of efficacy and efficiency.

Conditions

Colon Polyps

Keywords

polypectomy; cold snare; hot snare; cold forceps

Outcome Measures

Primary Outcomes (3)

• Incomplete resection rate

  Rate of recurrent neoplasia at polypectomy site

  3 years up to 5 years

• Patient participation

  Rates of patient refusal, participation, ineligibility and requirement for a 3-years vs. 5-year surveillance colonoscopy

  3 years up to 5 years

• Sample size calculation

  Sample size required for a definitive, adequately powered trial.

  3 years up to 5 years

Secondary Outcomes (1)

• Efficiency of polypectomy

  3 years up to 5 years

Study Arms (3)

Cold forceps

ACTIVE COMPARATOR

4-6mm polyps were removed with cold forceps

Procedure: Cold forceps

Cold snare

ACTIVE COMPARATOR

4-6mm polyps were removed with cold snare

Procedure: Cold snare

Hot snare

ACTIVE COMPARATOR

4-6mm polyps were removed with hot snare

Procedure: Hot snare

Interventions

Cold forceps PROCEDURE

Cold forceps

Cold snare PROCEDURE

Cold snare

Hot snare PROCEDURE

Hot snare

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons undergoing screening, surveillance, or diagnostic colonoscopy who are found to have 1 or more adenomatous colon polyps 4-6 mm in size with Paris morphology of types I or IIa in well-defined segments of the colon.

You may not qualify if:

• Inability to provide informed consent
• Requirement for long-term anticoagulation or clopidogrel (Plavix)
• Known International normalized ratio (INR) ≥ 1.5
• Less than satisfactory colon preparation quality
• Inability to intubate the cecum or reach the surgical anastomosis in case of cecectomy
• Age greater than 75
• Inpatient status (acute lower GI bleeding, etc.)
• Comorbidity that precludes the need for surveillance
• Pregnancy
• Already included in the protocol
• Pre- solid organ transplantation

Sponsors & Collaborators

• Indiana University: lead
• American Society for Gastrointestinal Endoscopy: collaborator

Study Sites (3)

Springmill endoscopy center

Carmel, Indiana, 46290, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Wishard Memorial Hospital/Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

Related Publications (4)

• Tolliver KA, Rex DK. Colonoscopic polypectomy. Gastroenterol Clin North Am. 2008 Mar;37(1):229-51, ix. doi: 10.1016/j.gtc.2007.12.009.

  PMID: 18313548 BACKGROUND

• Gomez V, Badillo RJ, Crook JE, Krishna M, Diehl NN, Wallace MB. Diminutive colorectal polyp resection comparing hot and cold snare and cold biopsy forceps polypectomy. Results of a pilot randomized, single-center study (with videos). Endosc Int Open. 2015 Feb;3(1):E76-80. doi: 10.1055/s-0034-1390789. Epub 2014 Nov 19.

  PMID: 26134778 BACKGROUND

• Desai S, Gupta S, Copur-Dahi N, Krinsky ML. A prospective randomized study comparing jumbo biopsy forceps to cold snare for the resection of diminutive colorectal polyps. Surg Endosc. 2020 Mar;34(3):1206-1213. doi: 10.1007/s00464-019-06874-z. Epub 2019 Jun 10.

  PMID: 31183796 BACKGROUND

• Lee CK, Shim JJ, Jang JY. Cold snare polypectomy vs. Cold forceps polypectomy using double-biopsy technique for removal of diminutive colorectal polyps: a prospective randomized study. Am J Gastroenterol. 2013 Oct;108(10):1593-600. doi: 10.1038/ajg.2013.302. Epub 2013 Sep 17.

  PMID: 24042189 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Imperiale, M.D.

  Indiana University

  STUDY CHAIR

• Hala Fatima, M.D.

  IUHP

  PRINCIPAL INVESTIGATOR

• Douglas Rex

  Indiana University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participant did not know which polypectomy technique was used. Endoscopists could not be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: There were 3 arms: cold forceps, cold snare, hot snare. Randomization was computer generated. Subjects were assigned to one of the 3 arms. Up to 5 study polyps were removed under research protocol from each subject using the same technique

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 14, 2020
• Study Start: September 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2019
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)