Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
NCT ID: NCT06462521
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
570 participants
INTERVENTIONAL
2024-09-06
2028-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cold Snare Piecemeal Resection (CSPR)
Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using CSPR technique.
Cold Snare Piecemeal Resection (CSPR)
Qualifying polyps randomized to Cold Snare Piecemeal Resection (CSPR) will be removed using cold snare techniques (no electrocautery, no submucosal injection.)
Cold Snare Endoscopic Mucosal Resection (Cold EMR)
Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using Cold EMR technique.
Cold Snare Endoscopic Mucosal Resection (Cold EMR)
Qualifying polyps randomized to Cold Snare Endoscopic Mucosal Resection (Cold EMR) will be removed using cold snare techniques (no electrocautery, with submucosal injection.)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cold Snare Piecemeal Resection (CSPR)
Qualifying polyps randomized to Cold Snare Piecemeal Resection (CSPR) will be removed using cold snare techniques (no electrocautery, no submucosal injection.)
Cold Snare Endoscopic Mucosal Resection (Cold EMR)
Qualifying polyps randomized to Cold Snare Endoscopic Mucosal Resection (Cold EMR) will be removed using cold snare techniques (no electrocautery, with submucosal injection.)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Presenting for a screening, surveillance, diagnostic, or therapeutic colonoscopy
3. 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)
4. Ability to provide informed consent
Exclusion Criteria
2. 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)
3. Patients with Ulcerative Colitis or Crohn's disease
4. Polyps with features suggestive of submucosal invasion
5. Polyps that are not able to be removed endoscopically due to location (e.g. extending into appendiceal orifice or diverticulum)
6. 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
7. Subjects whose colonoscopy procedure is not able to be completed due to bowel prep precluding polyp identification.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rush University Medical Center
OTHER
University of Colorado, Denver
OTHER
John D. Dingell VA Medical Center
FED
White River Junction Veterans Affairs Medical Center
FED
University of Kansas Medical Center
OTHER
Vancouver Coastal Health
OTHER_GOV
Université de Montréal
OTHER
University of Alabama at Birmingham
OTHER
Indiana University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
John J. Guardiola
Assistant Professor of Clinical Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John J Guardiola, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Indiana University
Indianapolis, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20831
Identifier Type: -
Identifier Source: org_study_id