Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04964869
Status:
RECRUITING
Last Update Posted:
2024-10-24
First Post:
2021-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2021-07-08', 'studyFirstSubmitQcDate': '2021-07-08', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post EST bleeding rate', 'timeFrame': '30 days', 'description': 'delay post-sphincterotomy bleeding rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sphincterotomy', 'epinephrine solution'], 'conditions': ['Bleeding Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Bleeding is the most frequently reported serious complication of endoscopic sphincterotomy, and severe bleeding has occurred in about 1% to 2% of patients. Endoscopic injection of epinephrine is the most commonly used, effective, and least expensive method for the management of post- sphincterotomy bleeding. However, the efficacy of prophylactic saline-epinephrine solution injection to prevent delayed EST bleeding when transient bleeding During ERCP has not been established.', 'detailedDescription': 'Backgroud:\n\nBleeding is the most frequently reported serious complication of endoscopic sphincterotomy, and severe bleeding has occurred in about 1% to 2% of patients. Endoscopic injection of epinephrine is the most commonly used, effective, and least expensive method for the management of post- sphincterotomy bleeding. However, the efficacy of prophylactic saline-epinephrine solution injection to prevent delayed EST bleeding when transient bleeding During ERCP has not been established.\n\nStudy Rationale:\n\nThe hypotheses of the study is the prophylactic saline-epinephrine solution injection affects incidence of delayed post-EST bleeding.\n\nStudy Design:\n\nA single blinded parallel group, multiple center, randomized controlled trial. The sample size is estimated 400 (200 in injection group and 200 in non-injection group), The primary outcome is the rate of delayed EST bleeding within 30 days of ERCP.\n\nStudy Objectives:\n\nPrimary objective: the rate of post-EST bleeding within 30 days of ERCP Secondary objectives: the rate of post-ERCP advese effect, the increasing procedure time because of hemostasis, the need for angiographic/endoscopic hemostasis times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20 years or older.\n* Ability to give informed consent.\n* An naive major papilla.\n* Transient bleeding after endoscopic sphincterotomy\n* Bleeding less than 30 secs when end of procedure\n\nExclusion Criteria:\n\n* Prior endoscopic sphincterotomy.\n* Thrombocytopenia (platelets \\<50,000/mm3).\n* Liver cirrhosis (Child A-C)\n* CKD stage 4-5 and dialysis.\n* Allergy to epinephrine\n* Prolonged PT/APTT (INR\\>1.5)\n* Had exposure any antithrombotic or antiplatelet agent in recent 7 days and/or will take those agents in one month after EST\n* Ampulla Vater tumor\n* Active GI bleeding\n* Pregnancy\n* Limited visibility when immediate bleeding after sphincterotomy\n* Still bleeding after 30 secs when end of procedure\n* Recurrent bleeding during ERCP'}, 'identificationModule': {'nctId': 'NCT04964869', 'briefTitle': 'Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients with Transient Bleeding During ERCP', 'orgStudyIdInfo': {'id': 'CMUH110-REC2-055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epinephrine solution injection group', 'description': "In injected group, The saline epinephrine solution (1mg in 10ml N/S) is injected to 2 sites of cutted papilla (1 o'clock and 11 o'clock) by injected needle, at least 0.5ml per injected site, and must be protruded from submucosal layer.", 'interventionNames': ['Procedure: epinephrine solution injection']}, {'type': 'NO_INTERVENTION', 'label': 'non-injection group', 'description': 'In non injection group, the saline epinephrine solution is not given'}], 'interventions': [{'name': 'epinephrine solution injection', 'type': 'PROCEDURE', 'description': 'epinephrine solution injection at least 1 ml to the post- sphincterotomy wound', 'armGroupLabels': ['Epinephrine solution injection group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404332', 'city': 'Taichung', 'state': 'North Dist.', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shih-Chieh Chuang, MD', 'role': 'CONTACT', 'email': 'D18114@mail.cmuh.org', 'phone': '+886-975680839'}], 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Shih-Chieh Chuang, MD', 'role': 'CONTACT', 'email': 'D18114@mail.cmuh.org.tw', 'phone': '+886-975680839'}, {'name': 'Wen-Hsin Huang, MD', 'role': 'CONTACT', 'email': 'u97766.huang@msa.hinet.net', 'phone': '+886-4-2205-2121', 'phoneExt': '2233'}], 'overallOfficials': [{'name': 'Wen-Hsin Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wen-Hsin Huang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Gastroenterology and Hepatology Deputy Director', 'investigatorFullName': 'Wen-Hsin Huang', 'investigatorAffiliation': 'China Medical University Hospital'}}}}