Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection

NCT06462521 | Enrolling By Invitation

• 1 other identifier: 20831
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

Brief Summary

The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.

Conditions

Colon Cancer; Colon Polyp; Colon Adenoma; Serrated Polyp

Keywords

Polyp Resection; Cold Snare; Cold Endoscopic Mucosal Resection (Cold EMR); Cold Snare Piecemeal Resection (CSPR); Colonoscopy

Outcome Measures

Primary Outcomes (2)

• Efficacy of Resection (Central Post-Resection Biopsies)

  Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.

  1 day

• Efficacy of Resection (Peripheral Post-Resection Biopsies)

  Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.

  1 day

Secondary Outcomes (5)

• Polyp Resection Time

  1 day

• Resection Preparation Time

  1 day

• Total Procedure Time

  1 day

• Adverse Events

  30 Days

• Rate of Recurrence at First Surveillance Colonoscopy for Polyps ≥ 20mm

  At first surveillance colonoscopy, typically 6 months to 12 months

Study Arms (2)

Cold Snare Piecemeal Resection (CSPR)

EXPERIMENTAL

Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using CSPR technique.

Procedure: Cold Snare Piecemeal Resection (CSPR)

Cold Snare Endoscopic Mucosal Resection (Cold EMR)

EXPERIMENTAL

Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using Cold EMR technique.

Procedure: Cold Snare Endoscopic Mucosal Resection (Cold EMR)

Interventions

Cold Snare Piecemeal Resection (CSPR) PROCEDURE

Qualifying polyps randomized to Cold Snare Piecemeal Resection (CSPR) will be removed using cold snare techniques (no electrocautery, no submucosal injection.)

Cold Snare Piecemeal Resection (CSPR)

Cold Snare Endoscopic Mucosal Resection (Cold EMR) PROCEDURE

Qualifying polyps randomized to Cold Snare Endoscopic Mucosal Resection (Cold EMR) will be removed using cold snare techniques (no electrocautery, with submucosal injection.)

Cold Snare Endoscopic Mucosal Resection (Cold EMR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Presenting for a screening, surveillance, diagnostic, or therapeutic colonoscopy
• Found to have:
• a sessile serrated lesion or hyperplastic polyp ≥ 10 mm during procedure (Serrated Cohort) or
• a 10-19 mm conventional adenoma during procedure (Adenoma Cohort)
• Ability to provide informed consent

You may not qualify if:

• Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
• Polyps confirmed to be anything other than:
• sessile serrated lesion or hyperplastic polyp on histologic diagnosis (Serrated Cohort) or
• conventional adenoma on histologic diagnosis (Adenoma Cohort)
• Patients with Ulcerative Colitis or Crohn's disease
• Polyps with features suggestive of submucosal invasion
• Polyps that are not able to be removed endoscopically due to location (e.g. extending into appendiceal orifice or diverticulum)
• Patients with a known or suspected diagnosis of any of the following polyposis syndromes with known genetic mutations:
• Familial Adenomatous Polyposis Syndrome
• MUTYH associated Polyposis Syndrome
• Juvenile Polyposis Syndrome
• Cowden's Syndrome
• Peutz-Jeghers Syndrome
• Subjects whose colonoscopy procedure is not able to be completed due to bowel prep precluding polyp identification.

Sponsors & Collaborators

• Indiana University: lead
• Rush University Medical Center: collaborator
• University of Colorado, Denver: collaborator
• John D. Dingell VA Medical Center: collaborator
• White River Junction Veterans Affairs Medical Center: collaborator
• University of Kansas Medical Center: collaborator
• Vancouver Coastal Health: collaborator
• Université de Montréal: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (7)

• Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1095-1129. doi: 10.1053/j.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available.

  PMID: 32122632 BACKGROUND

• von Renteln D, Djinbachian R, Benard F, Barkun AN, Bouin M, Bouchard S, Deslandres E, Panzini B, Sidani S, Leduc R, Jobse BC, Pohl H. Incomplete resection of colorectal polyps of 4-20 mm in size when using a cold snare, and its associated factors. Endoscopy. 2023 Oct;55(10):929-937. doi: 10.1055/a-1978-3277. Epub 2022 Nov 14.

  PMID: 36377124 BACKGROUND

• McWhinney CD, Vemulapalli KC, El Rahyel A, Abdullah N, Rex DK. Adverse events and residual lesion rate after cold endoscopic mucosal resection of serrated lesions >/=10 mm. Gastrointest Endosc. 2021 Mar;93(3):654-659. doi: 10.1016/j.gie.2020.08.032. Epub 2020 Sep 3.

  PMID: 32891621 RESULT

• Rex DK, Anderson JC, Pohl H, Lahr RE, Judd S, Antaki F, Lilley K, Castelluccio PF, Vemulapalli KC. Cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2022 Aug;96(2):330-338. doi: 10.1016/j.gie.2022.03.006. Epub 2022 Mar 12.

  PMID: 35288147 RESULT

• Kimoto Y, Sakai E, Inamoto R, Kurebayashi M, Takayanagi S, Hirata T, Suzuki Y, Ishii R, Konishi T, Kanda K, Negishi R, Takita M, Ono K, Minato Y, Muramoto T, Ohata K. Safety and Efficacy of Cold Snare Polypectomy Without Submucosal Injection for Large Sessile Serrated Lesions: A Prospective Study. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e132-e138. doi: 10.1016/j.cgh.2020.10.053. Epub 2020 Nov 2.

  PMID: 33152541 RESULT

• Mangira D, Raftopoulos S, Vogrin S, Hartley I, Mack A, Gazelakis K, Nalankilli K, Trinh A, Metz AJ, Appleyard M, Grimpen F, Elliott T, Brown G, Moss A. Effectiveness and safety of cold snare polypectomy and cold endoscopic mucosal resection for nonpedunculated colorectal polyps of 10-19 mm: a multicenter observational cohort study. Endoscopy. 2023 Jul;55(7):627-635. doi: 10.1055/a-2029-9539. Epub 2023 Feb 7.

  PMID: 36750222 RESULT

• Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.

  PMID: 32044092 RESULT

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• John J Guardiola, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: September 6, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)