Clinical trial NCT06462521: 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)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Rush University Medical Center
name: University of Colorado, Denver
name: John D. Dingell VA Medical Center
name: Carilion Clinic
name: White River Junction Veterans Affairs Medical Center
name: The University of Kansas Medical Center
name: Vancouver Coastal Health
name: Université de Montréal
name: University of Alabama at Birmingham
name: The Methodist Hospital Research Institute
First posted: 2024-06-17
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age
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:

1. Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
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.

Primary outcomes:
measure: Efficacy of Resection (Central Post-Resection Biopsies)
timeFrame: 1 day
measure: Efficacy of Resection (Peripheral Post-Resection Biopsies)
timeFrame: 1 day
Secondary outcomes:
measure: Polyp Resection Time
timeFrame: 1 day
measure: Resection Preparation Time
timeFrame: 1 day
measure: Total Procedure Time
timeFrame: 1 day
measure: Adverse Events
timeFrame: 30 Days
measure: Rate of Recurrence at First Surveillance Colonoscopy for Polyps ≥ 20mm
timeFrame: At first surveillance colonoscopy, typically 6 months to 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: John J Guardiola, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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 2020 Sep 3.
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. 2022 Aug;96(2):330-338. doi: 10.1016/j.gie.2022.03.006. Epub 2022 Mar 12.
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 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.
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 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.
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.
citation: 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.