Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05250518
Status:
UNKNOWN
Last Update Posted:
2022-02-22
First Post:
2022-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Argon Plasma Coagulation and Clip for the Prophylaxis of Post-polypectomy Bleeding After Hot Snare Polypectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057908', 'term': 'Argon Plasma Coagulation'}, {'id': 'D013525', 'term': 'Surgical Instruments'}], 'ancestors': [{'id': 'D004564', 'term': 'Electrocoagulation'}, {'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D006488', 'term': 'Hemostasis, Surgical'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1017}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-21', 'studyFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2022-02-21', 'lastUpdatePostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of re-bleeding', 'timeFrame': '30 days after HSP', 'description': 'the rate of re-bleeding within 30 days after operation'}], 'secondaryOutcomes': [{'measure': 'Location of re-bleeding sites', 'timeFrame': '30 days after HSP', 'description': "the original polyps' location of re-bleeding sites: cecum, ascending colon, colonic hepatic flexure, transverse colon, colonic splenic flexure , descending colon, sigmoid colon, rectum"}, {'measure': 'Other postoperative complications', 'timeFrame': '30 days after HSP', 'description': 'Other postoperative complications (perforation, electrocoagulation syndrome after polypectomy, stenosis, etc.)'}, {'measure': 'Expenses of prevention', 'timeFrame': 'the 1 day of discharge from medical centers', 'description': 'Expenses of argon plasma coagulation and clips'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hot snare polypectomy', 'argon plasma coagulation', 'clip closure'], 'conditions': ['Post-polypectomy Bleeding', 'Colorectal Polyp']}, 'descriptionModule': {'briefSummary': 'Discuss the efficacy and safety of argon plasma coagulation （APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）; analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.', 'detailedDescription': "This is a multicenter, randomized and controlled study. It aims to discuss the efficacy and safety of argon plasma coagulation（APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）, and analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.\n\nAccording to the prophylaxis measures, patients enrolled in this study will be randomized into the control group, APC group and Clip group. It will collect participants' data of baseline character, postoperative and follow-up. All statistical analyses will be performed by SPSS 26.0 and Tree Age Pro 2011.\n\nBased on the previous studies, it is presumed that the rate of PPB for the control group, Clip group and APC group is 8%, 2% and 2%. Given two-side testing, an alpha of 0.05 and a power of 90%, allowing for a 5% dropout rate, the smallest sample size is 1287."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age\\>18 years\n2. the diagnosis of colorectal polyps is clear（Paris Ip or Ⅰsp）\n3. head diameter≥ 10 mm\n4. HSP indications were met and no contraindications were found\n5. patients (or the legal representative/guardian) with informed consent\n\nExclusion Criteria:\n\n1. ASA Grade Ⅲ or above, or end-stage disease of major organs (such as malignancy, heart failure, chronic obstructive pulmonary disease, end-stage renal disease and so on)\n2. coagulation dysfunction (INR ≥ 1.5, PLT \\< 50×10 \\^9 / L)\n3. use antiplatelet drugs within 7 days before the operation, anticoagulant drugs within 5 days, and/or blood products within 30 days after the operation\n4. there were other lesions in the resection site of the included polyps affecting this study, or the intestinal preparation was insufficient\n5. incomplete closure of clips (complete closure: spacing between adjacent clips \\< 1cm)\n6. APC is used for polypectomy or intraoperative hemostasis, rather than preventing PPB\n7. surgical treatment, vascular intervention, or blood products were used during the operation\n8. use other methods to prevent PPB\n9. the bleeding site was not confirmed by endoscopy\n10. history of intestinal surgery\n11. menstruation or pregnancy\n12. not following medical advice\n13. participated in other clinical trials and signed its informed consent'}, 'identificationModule': {'nctId': 'NCT05250518', 'acronym': 'APC、HSP', 'briefTitle': 'Argon Plasma Coagulation and Clip for the Prophylaxis of Post-polypectomy Bleeding After Hot Snare Polypectomy', 'organization': {'class': 'OTHER', 'fullName': 'Renmin Hospital of Wuhan University'}, 'officialTitle': 'Comparison of Argon Plasma Coagulation and Clip Closure for the Prophylaxis of Colorectal Post-polypectomy Bleeding After Hot Snare Polypectomy: a Multicenter, Randomized and Controlled Study', 'orgStudyIdInfo': {'id': 'WDRY2022-K018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'the control group', 'description': 'The control group will receive no prophylaxis of post-procedure bleeding.'}, {'type': 'EXPERIMENTAL', 'label': 'APC group', 'description': 'The APC group will receive prophylaxis of post-procedure bleeding with argon plasma coagulation.', 'interventionNames': ['Procedure: argon plasma coagulation']}, {'type': 'EXPERIMENTAL', 'label': 'Clip group', 'description': 'The Clip group will receive prophylaxis of post-procedure bleeding with clip closure.', 'interventionNames': ['Procedure: clip closure']}], 'interventions': [{'name': 'argon plasma coagulation', 'type': 'PROCEDURE', 'description': 'After hot snare polypectomy, participants will be randomized assigned to the APC group for argon plasma coagulation to prevent colorectal post-procedure bleeding.', 'armGroupLabels': ['APC group']}, {'name': 'clip closure', 'type': 'PROCEDURE', 'description': 'After hot snare polypectomy, participants will be randomized assigned to the Clip group for complete closure(spacing between adjacent clips \\< 1cm) to prevent colorectal post-procedure bleeding.', 'armGroupLabels': ['Clip group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Mingkai Chen, Ph.D & M.D', 'role': 'CONTACT', 'email': 'chenmingkai@whu.edu.cn', 'phone': '+86 13720330580'}], 'overallOfficials': [{'name': 'Mingkai Chen, Ph.D & M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Renmin Hospital of Wuhan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'ChenMingkai', 'investigatorAffiliation': 'Renmin Hospital of Wuhan University'}}}}