Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection

Colon Cancer Clinical Trial

— CARDINAL  

Official title:

Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection: A RandomizeD Trial IN Colorectal Adenomas 10-19mm and Serrated Lesions ≥ 10mm (CARDINAL Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462521
• Other study ID #: 20831
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: Indiana University
• Contact: Lainna R Cohen, MSW
• Phone: 317-278-0621
• Email: larcohen[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 285
• Est. completion date: January 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 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

Exclusion Criteria:

• 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

• Polyps confirmed to be anything other than 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)

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colon Cancer
• Colon Polyp
• Polyps
• Serrated Polyp

Intervention

Procedure:
• 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.)

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (9)

Lead Sponsor	Collaborator
Indiana University	Carilion Clinic, John D. Dingell VA Medical Center, Minneapolis Veterans Affairs Medical Center, Rush University Medical Center, The University of Kansas Medical Center, Université de Montréal, Vancouver Coastal Health, White River Junction Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (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. — View Citation

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. — View Citation

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 Ses — View Citation

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 nonpeduncu — View Citation

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 — View Citation

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. 2 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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