[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06462521":3,"trial-entities:NCT06462521":127,"trial-summary:NCT06462521":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":45,"secondary_outcomes":52,"sex":70,"minimum_age":71,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":72,"std_ages":85,"locations":88,"central_contacts":97,"overall_officials":98,"references":102,"see_also_links":126},"NCT06462521","20831","Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection","Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection: A RandomizeD Trial IN Colorectal Adenomas 10-19mm and Serrated Lesions ≥ 10mm (CARDINAL Study)","ENROLLING_BY_INVITATION","2028-07","2025-09","2025-12-30","2024-09-06","Indiana University","OTHER",false,"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.",null,[19,20,21,22],"Colon Cancer","Colon Polyp","Colon Adenoma","Serrated Polyp",[24,25,26,27,28],"Polyp Resection","Cold Snare","Cold Endoscopic Mucosal Resection (Cold EMR)","Cold Snare Piecemeal Resection (CSPR)","Colonoscopy","INTERVENTIONAL","PREVENTION",[32],"NA",{"count":34,"type":35},570,"ESTIMATED",[37,41],{"type":38,"name":27,"description":39,"armGroupLabels":40},"PROCEDURE","Qualifying polyps randomized to Cold Snare Piecemeal Resection (CSPR) will be removed using cold snare techniques (no electrocautery, no submucosal injection.)",[27],{"type":38,"name":42,"description":43,"armGroupLabels":44},"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.)",[42],[46,50],{"measure":47,"description":48,"timeFrame":49},"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",{"measure":51,"description":48,"timeFrame":49},"Efficacy of Resection (Peripheral Post-Resection Biopsies)",[53,56,59,62,66],{"measure":54,"description":55,"timeFrame":49},"Polyp Resection Time","The time it takes to remove the polyp completely",{"measure":57,"description":58,"timeFrame":49},"Resection Preparation Time","The time it takes to prepare for polyp removal",{"measure":60,"description":61,"timeFrame":49},"Total Procedure Time","The total time it takes to complete the colonoscopy procedure",{"measure":63,"description":64,"timeFrame":65},"Adverse Events","The number of complications for each randomization arm during and after the procedure","30 Days",{"measure":67,"description":68,"timeFrame":69},"Rate of Recurrence at First Surveillance Colonoscopy for Polyps ≥ 20mm","The recurrence rate of serrated lesions ≥ 20mm measured at the first follow-up colonoscopy","At first surveillance colonoscopy, typically 6 months to 12 months","ALL","18 Years",{"inclusion":73,"exclusion":76,"raw_text":84},[74,75],"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",[77,78,79,80,81,82,83],"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.","Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. Presenting for a screening, surveillance, diagnostic, or therapeutic colonoscopy\n3. Found to have:\n\n   * a sessile serrated lesion or hyperplastic polyp ≥ 10 mm during procedure (Serrated Cohort) or\n   * a 10-19 mm conventional adenoma during procedure (Adenoma Cohort)\n4. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)\n2. Polyps confirmed to be anything other than:\n\n   * sessile serrated lesion or hyperplastic polyp on histologic diagnosis (Serrated Cohort) or\n   * conventional adenoma on histologic diagnosis (Adenoma Cohort)\n3. Patients with Ulcerative Colitis or Crohn's disease\n4. Polyps with features suggestive of submucosal invasion\n5. Polyps that are not able to be removed endoscopically due to location (e.g. extending into appendiceal orifice or diverticulum)\n6. Patients with a known or suspected diagnosis of any of the following polyposis syndromes with known genetic mutations:\n\n   * Familial Adenomatous Polyposis Syndrome\n   * MUTYH associated Polyposis Syndrome\n   * Juvenile Polyposis Syndrome\n   * Cowden's Syndrome\n   * Peutz-Jeghers Syndrome\n7. Subjects whose colonoscopy procedure is not able to be completed due to bowel prep precluding polyp identification.",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":13,"city":90,"state":91,"zip":92,"country":93,"geoPoint":94},"Indianapolis","Indiana","46202","United States",{"lat":95,"lon":96},39.76838,-86.15804,[],[99],{"name":100,"affiliation":13,"role":101},"John J Guardiola, MD","PRINCIPAL_INVESTIGATOR",[103,107,110,114,117,120,123],{"pmid":104,"type":105,"citation":106},"32122632","BACKGROUND","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\u002Fj.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available.",{"pmid":108,"type":105,"citation":109},"36377124","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\u002Fa-1978-3277. Epub 2022 Nov 14.",{"pmid":111,"type":112,"citation":113},"32891621","RESULT","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 >\u002F=10 mm. Gastrointest Endosc. 2021 Mar;93(3):654-659. doi: 10.1016\u002Fj.gie.2020.08.032. Epub 2020 Sep 3.",{"pmid":115,"type":112,"citation":116},"35288147","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\u002Fj.gie.2022.03.006. Epub 2022 Mar 12.",{"pmid":118,"type":112,"citation":119},"33152541","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\u002Fj.cgh.2020.10.053. Epub 2020 Nov 2.",{"pmid":121,"type":112,"citation":122},"36750222","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\u002Fa-2029-9539. Epub 2023 Feb 7.",{"pmid":124,"type":112,"citation":125},"32044092","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\u002Fj.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.",[],{"nct_id":4,"conditions":128,"biomarkers":130},[21,129],"Serrated polyp",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]