Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT02156193
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2014-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Pedunculated Colonic Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2014-06-03', 'studyFirstSubmitQcDate': '2014-06-04', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postpolypectomy bleeding', 'timeFrame': '1 month', 'description': 'Immediate and delayed postpolypectomy bleeding'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bleeding']}, 'referencesModule': {'references': [{'pmid': '33417897', 'type': 'DERIVED', 'citation': 'Gweon TG, Lee KM, Lee SW, Kim DB, Ji JS, Lee JM, Chung WC, Paik CN, Choi H. Effect of prophylactic clip application for the prevention of postpolypectomy bleeding of large pedunculated colonic polyps: a randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):148-154. doi: 10.1016/j.gie.2020.12.040. Epub 2021 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Preventive methods such as endoloop and epinephrine injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no randomized controlled study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So the investigators designed a randomized controlled trial to confirm the efficacy of application of prophylactic clip in the prevention of postpolypectomy bleeding in large polyps.', 'detailedDescription': 'Patients who had pedunculated colorectal polyps with heads larger than 10 mm and stalks larger than 5 mm in diameter were included. In clip group, hemoclips were applied to the base of the stalk, followed by conventional snare polypectomy. In conventional group, conventional snare polypectomy was done without any preventive management. Immediate and delayed bleeding complications were assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included.\n\nExclusion Criteria:\n\n* bleeding tendency, poor preparation, sessile polyp'}, 'identificationModule': {'nctId': 'NCT02156193', 'briefTitle': 'Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Pedunculated Colonic Polyps', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Large Pedunculated Colonic Polyps: a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'Clip control'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prophylactic clip', 'description': 'Before conventional snare polypectomy, hemoclips will be applied on the base of stalk.', 'interventionNames': ['Procedure: Prophylactic clip']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No prophylactic management', 'description': 'Conventional snare polypectomy will be performed without any preventive management.', 'interventionNames': ['Procedure: No prophylactic management']}], 'interventions': [{'name': 'Prophylactic clip', 'type': 'PROCEDURE', 'description': 'Prophylactic clipping', 'armGroupLabels': ['Prophylactic clip']}, {'name': 'No prophylactic management', 'type': 'PROCEDURE', 'description': 'No prophylaxis', 'armGroupLabels': ['No prophylactic management']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'country': 'South Korea', 'facility': "Incheon St. Mary's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'overallOfficials': [{'name': 'Jeong-Seon Ji, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Incheon St. Mary's Hospital, The Catholic University of Korea"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Jeong-Seon Ji', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}