Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-27 @ 9:52 AM
Study NCT ID:
NCT04816292
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018256', 'term': 'Adenomatous Polyps'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 850}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete resection rate', 'timeFrame': '6 months', 'description': 'The histological complete resection rate, determined by pathologically negative margins of the specimen and no residual adenomatous material obtained from two/four biopsies of the resection site.'}], 'secondaryOutcomes': [{'measure': 'En-bloc resection rate', 'timeFrame': 'During procedure', 'description': 'Number of additional resections (snare/forceps) needed.'}, {'measure': 'Rate of immediate bleeding with necessity of haemostasis', 'timeFrame': 'During procedure', 'description': 'Immediate bleeding: Bleeding \\>30 seconds after snaring.'}, {'measure': 'Rate of impossible resection by CSP', 'timeFrame': 'During procedure', 'description': 'An impossible resection by CSP needs electrocautery for successful resection.'}, {'measure': 'Time required for resection', 'timeFrame': 'During procedure', 'description': 'Time required for resection is the time between the insertion of the snare into working channel to the end of polyp resection. In the HSP group, it is defined as the start of submucosal injection until the end of polyp resection.'}, {'measure': 'Rate of procedure-related adverse events.', 'timeFrame': '6 months', 'description': 'Delayed bleeding, defined as haemorrhage after colonoscopy with the necessity of endoscopic haemostasis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adenomatous Polyps']}, 'descriptionModule': {'briefSummary': 'Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 19 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps \\<5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen.\n\nIn this randomized controlled trial, the investigators want to compare the complete resection rates of small and intermediate sized colorectal polyps 10-15 mm with CSP and HSP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for colonoscopy\n* at least 1 adenomatous polyp 10-15 mm\n* provided written informed consent\n\nExclusion Criteria:\n\n* American Society of Anaesthesiologists class IV or higher\n* florid inflammatory bowel disease\n* emergency indication for colonoscopy\n* haemorrhagic diathesis\n* continued dual antiplatelet therapy\n* continued anticoagulant therapy'}, 'identificationModule': {'nctId': 'NCT04816292', 'acronym': 'COLDSNAP-2', 'briefTitle': 'A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm)', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm) - a Randomized Controlled Trial (COLDSNAP-2)', 'orgStudyIdInfo': {'id': '2021-90-S-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hot Snare Polypectomy', 'description': 'If an eligible polyp 10-15 mm (as compared by the size of the snare) is found, according to the randomized group, HSP is performed for the removal of all eligible polyps in this patient. After polypectomy, the resection site is washed thoroughly with saline water. After the endoscopist carefully examines the resection site for residual adenomatous tissue, eventually another resection with the same method is indicated. Afterwards 4 biopsies (polyps 10-15mm) are performed from the resection margin to reveal presence or absence of residual neoplastic tissue.', 'interventionNames': ['Procedure: Active Comparator: Hot Snare Polypectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Cold Snare Polypectomy', 'description': 'If an eligible polyp 10-15 mm (as compared by the size of the snare) is found, according to the randomized group, CSP is performed for the removal of all eligible polyps in this patient. After polypectomy, the resection site is washed thoroughly with saline water. After the endoscopist carefully examines the resection site for residual adenomatous tissue, eventually another resection with the same method is indicated. Afterwards 4 biopsies (polyps 10-15mm) are performed from the resection margin to reveal presence or absence of residual neoplastic tissue.', 'interventionNames': ['Procedure: Experimental: Cold Snare Polypectomy']}], 'interventions': [{'name': 'Active Comparator: Hot Snare Polypectomy', 'type': 'PROCEDURE', 'description': 'Hot Snare Polypectomy with the use of electrocautery for the resection of polyps.', 'armGroupLabels': ['Hot Snare Polypectomy']}, {'name': 'Experimental: Cold Snare Polypectomy', 'type': 'PROCEDURE', 'description': 'Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.', 'armGroupLabels': ['Cold Snare Polypectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'München', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jörg Ulrich, MD', 'role': 'CONTACT', 'email': 'joerg.ulrich@mri.tum.de', 'phone': '+498941408004'}, {'name': 'Veit Phillip, MD', 'role': 'CONTACT', 'email': 'veit.phillip@mri.tum.de', 'phone': '+498941409350'}, {'name': 'Jörg Ulrich, MD', 'role': 'CONTACT'}], 'facility': 'Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technische Universität München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}], 'centralContacts': [{'name': 'Veit Phillip, MD', 'role': 'CONTACT', 'email': 'veit.phillip@mri.tum.de', 'phone': '+49894140', 'phoneExt': '9350'}, {'name': 'Joerg Ulrich, MD', 'role': 'CONTACT', 'email': 'joerg.ulrich@mri.tum.de', 'phone': '+49894140', 'phoneExt': '8004'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Departement for Interdisciplinary Endoscopy', 'investigatorFullName': 'Veit Phillip', 'investigatorAffiliation': 'Technical University of Munich'}}}}