Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection

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)

Overview

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.

Interventions

• 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.)
• Procedure 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.)

Primary outcome measures

• Efficacy of Resection (Central Post-Resection Biopsies) [Time frame: 1 day]
• Efficacy of Resection (Peripheral Post-Resection Biopsies) [Time frame: 1 day]

Secondary outcome measures (5)

• Polyp Resection Time [Time frame: 1 day]
• Resection Preparation Time [Time frame: 1 day]
• Total Procedure Time [Time frame: 1 day]
• Adverse Events [Time frame: 30 Days]
• Rate of Recurrence at First Surveillance Colonoscopy for Polyps ≥ 20mm [Time frame: At first surveillance colonoscopy, typically 6 months to 12 months]

Eligibility criteria

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
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Indiana University — Indianapolis

Publications

• 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
• 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
• 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
• 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
• 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
• 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 PMID 36750222
• 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

Identifiers

NCT: NCT06462521 · 20831

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗