Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT07242820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Neoplasia Recurrence After Non-thermal Endoscopic Resection of Large Colorectal Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 752}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2031-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'High-grade dysplasia rate at the 18-month follow-up', 'timeFrame': '18 months', 'description': 'Defined as the number of cases with high-grade dysplasia on resection scars divided by the total number of cases.'}, {'measure': 'Rate of CRC during the 18-month follow-up period', 'timeFrame': 'From enrollment to the final follow-up colonoscopy at 18 months', 'description': 'Defined as the number of cases with pathology-confirmed carcinomas divided by the total number of cases.'}, {'measure': 'Colonoscopies to lesion clearance', 'timeFrame': '18 months', 'description': 'Defined as the total number of colonoscopies required to achieve lesion clearance, which means no histologic recurrence at the resection scar on follow-up.'}, {'measure': 'EMR procedure time', 'timeFrame': '1 day', 'description': 'Defined as the length of time required for the initial EMR.'}, {'measure': 'Rate of delayed bleeding in the proximal colon', 'timeFrame': '14 days', 'description': 'Number of cases with clinically significant delayed bleeding in the proximal colon (proximal to the splenic flexure) divided by the total number of cases.'}, {'measure': 'Defect closure time', 'timeFrame': '1 day', 'description': 'Time required for defect closure.'}, {'measure': 'Rate of technical success for complete defect closure', 'timeFrame': '6 months', 'description': 'Number of cases with technical success for complete defect closure (defined as adequate apposition of the mucosal defect margins without visible submucosal areas \\>3mm along the closure line) divided by total number of cases.'}, {'measure': 'Costs associated with procedures', 'timeFrame': 'From enrollment to the final follow-up colonoscopy at 18 months', 'description': 'Total costs required to perform non-thermal EMR with adjuvant thermal ablation or without ablation.'}], 'primaryOutcomes': [{'measure': 'Lesion recurrence rate', 'timeFrame': '6 months', 'description': 'Defined as the number of cases with pathology-confirmed hyperplastic, serrated, or adenomatous histology at the tattooed resection site compatible with the study polyp histology divided by the total number of cases.'}, {'measure': 'Clinically significant adverse event (AE) rate', 'timeFrame': '14 days', 'description': 'Defined as the number of cases with delayed bleeding (blood per rectum resulting in emergency room visit, unplanned hospitalization, endoscopic, radiologic, or surgical intervention) and/or delayed perforation (endoscopic or radiologic evidence of significant air or any luminal contents outside the gastrointestinal tract) divided by the total number of cases.'}], 'secondaryOutcomes': [{'measure': 'Any delayed bleeding rate', 'timeFrame': '14 days', 'description': 'Defined as the number of cases with blood per rectum, regardless of clinical significance, divided by the total number of cases.'}, {'measure': 'Lesion recurrence rate at 18-month follow-up', 'timeFrame': '18 months', 'description': 'Defined as the number of cases with pathology-confirmed hyperplastic, serrated, or adenomatous histology at the tattooed resection site compatible with the study polyp histology divided by the total number of cases.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Polyp of Colon']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to clarify the role of adjuvant thermal ablation for non-thermal endoscopic mucosal resection (EMR) of large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions \\[LSLs\\]).\n\nThe hypothesis is that adding adjuvant thermal ablation to non-thermal EMR (vs no ablation) will result in lower lesion recurrence rates at 6-month follow-up, and non-inferior adverse events (AE) rates 14 days post EMR.\n\nFor participants with planned EMR, endoscopists will perform non-thermal EMRs as per standard of care and:\n\n* adjuvant thermal ablation will either not be performed (control group), or will be applied to the base and outside margins of the resection site (experimental group);\n* then, all patients will be contacted 14-44 days after EMR, to verbally ascertain the occurrence of AEs;\n* then, all patients will undergo a first follow-up colonoscopy at 6 months after initial conoloscopy to assess lesion recurrence;\n* finally, all patients will undergo a second and final colonoscopy 18 months after EMR.', 'detailedDescription': 'This trial is an open-label, two-arm, parallel-group, multicenter RCT with co-primary outcomes (superiority for recurrence, non-inferiority for AEs). Patients undergoing non-thermal EMR will be randomized (1:1) to adjuvant thermal ablation (experimental group) or no ablation (control group).\n\nAll participating endoscopists will view dedicated teaching videos of the standard thermal ablation technique and key technical details to ensure consistent study procedures. Patients with planned EMR procedures will be invited by a research assistant before the EMR to participate in the study. Patients will be randomized to control or experimental groups in a 1:1 ratio using a central REDCap randomization module after the EMR resection phase is completed and immediately before adjuvant thermal ablation (intervention). This will limit bias by ensuring that the EMR technique is not affected by group allocation. When 2 or more lesions are present in a patient, the largest lesion will be chosen for inclusion in the study and all lesions will be photodocumented for auditing purposes.\n\nNo ablation (control group): Non-thermal EMR will be performed as per standard of care with submucosal injection and non-electrocautery resection of all visually visible polyp tissue using a snare. When the endoscopist determines that the resection is complete, no adjuvant thermal ablation of the post-EMR defect will be performed. Defect closure using clips will be performed only if there is concern for injury to the muscle layer or signs of overt perforation. A tattoo will be placed 3 cm distal to the resected lesion to allow for better identification of the resection site for follow-up. If multiple large polyps are found and removed, the largest lesion (study polyp) will be marked with two tattoos 3 cm distally and 3 cm proximally, to clearly identify the study polyp resection site.\n\nAdjuvant thermal ablation (experimental group): Non-thermal EMR will be performed as per standard of care with submucosal injection and non-electrocautery resection of all visually visible polyp tissue using a snare. When the endoscopist determines that the resection is complete, submucosal injection (0.9% NaCl with methylene blue solution) using the h-APC probe (ERBEJET 2 attached to Vio3 electrosurgical unit, pressure: 40 bar) will be performed to further expose the resection margin. Adjuvant thermal ablation will be applied to the outside margins of the resection site using the h-APC probe. Then, adjuvant thermal ablation will also be applied to the base of the resection site using the h-APC probe. The precise electrocautery mode (PRECISE-APC setting 9) will be used to apply thermal ablation, as previously described for h-APC. Defect closure using clips will be performed only if there is concern for injury to the muscle layer or signs of overt perforation. A tattoo will be placed in the same way as described in the control group and, again, if multiple large polyps are found and removed, the largest lesion (study polyp) will be marked with two tattoos 3 cm distally and 3 cm proximally, to clearly identify the study polyp resection site.\n\nAt 6 months after initial colonoscopy, patients will undergo a first follow-up colonoscopy, as suggested by current guidelines and from studies showing that most recurrences occurred within the first 6 months. A window of 3 to 13 months will be permitted for the first follow-up. If recurrence is detected, patients will undergo subsequent colonoscopies at shortened intervals, as determined by the treating endoscopist, until no recurrence is detected. If surgery is performed due to difficulty in treating recurrence, patients will undergo a follow-up colonoscopy 6 months after surgery to detect any possible recurrence. All patients will undergo a second and final study colonoscopy 18 months after randomization, which will also mark the end of study follow-up. The second follow-up may be conducted within a window of 14 to 24 months. Subsequent colonoscopies will then be recommended outside the study as per routine care for such a clinical situation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* Undergoing EMR for large (≥20 mm) colorectal LSL\n* Providing written and informed consent for study participation\n\nExclusion Criteria:\n\n* Inflammatory bowel disease\n* Non-elective colonoscopy\n* Poor general health (American Society of Anesthesiologists classification \\>III)\n* Coagulopathy or thrombocytopenia (international normalized ration ≥1.5 or platelets \\<50\\*10\\^9/L)\n* Bulky lesions (granular mixed with ≥10mm module).'}, 'identificationModule': {'nctId': 'NCT07242820', 'acronym': 'COSA-RCT', 'briefTitle': 'Reducing Neoplasia Recurrence After Non-thermal Endoscopic Resection of Large Colorectal Polyps', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Reducing Neoplasia Recurrence After Non-thermal Endoscopic Resection of Large Colorectal Polyps', 'orgStudyIdInfo': {'id': '2026-13165'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endoscopic mucosal resection (EMR) + adjuvant thermal ablation', 'description': 'Adjuvant thermal ablation will be applied to the base and outside margins of the resection site after non-thermal EMR.', 'interventionNames': ['Procedure: Adjuvant thermal ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endoscopic mucosal resection (EMR)', 'description': 'After non-thermal EMR, no adjuvant thermal ablation will be performed.', 'interventionNames': ['Procedure: No adjuvant thermal ablation']}], 'interventions': [{'name': 'Adjuvant thermal ablation', 'type': 'PROCEDURE', 'description': 'When the endoscopist determines that the resection is complete, submucosal injection (0.9% NaCl with methylene blue solution) using the h-APC probe (ERBEJET 2 attached to Vio3 electrosurgical unit, pressure: 40 bar) will be performed to further expose the resection margin. Adjuvant thermal ablation will be applied to the outside margins of the resection site using the h-APC probe.\n\nAdjuvant thermal ablation will then also be applied to the base of the resection site using the h-APC probe. The precise electrocautery mode (PRECISE-APC setting 9) will be used to apply thermal ablation, as previously described for h-APC.', 'armGroupLabels': ['Endoscopic mucosal resection (EMR) + adjuvant thermal ablation']}, {'name': 'No adjuvant thermal ablation', 'type': 'PROCEDURE', 'description': 'After performing non-thermal EMR with thermal ablation, adjuvant thermal ablation will not be performed.', 'armGroupLabels': ['Endoscopic mucosal resection (EMR)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Samira Hanin', 'role': 'CONTACT', 'email': 'samira.hanin.chum@ssss.gouv.qc.ca', 'phone': '514-890-8000', 'phoneExt': '30916'}, {'name': 'Daniel von Renteln, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Centre Hospitalier de l'Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Beginning 12 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).', 'accessCriteria': 'Proposals should be directed to daniel.von.renteln.med@ssss.gouv.qc.ca. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}