Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT03171805
Status:
UNKNOWN
Last Update Posted:
2021-11-23
First Post:
2017-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-20', 'studyFirstSubmitDate': '2017-05-26', 'studyFirstSubmitQcDate': '2017-05-26', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Worsening of esophageal varices rate', 'timeFrame': '3 years', 'description': 'Analysis'}], 'secondaryOutcomes': [{'measure': 'Variceal rebleeding rate', 'timeFrame': '3 years', 'description': 'Analysis'}, {'measure': 'Mortality rate', 'timeFrame': '3 years', 'description': 'Analysis'}, {'measure': 'Worsening of ascites rate', 'timeFrame': '3 years', 'description': 'Analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhoses', 'Portal Hypertension', 'Gastric Varix']}, 'descriptionModule': {'briefSummary': 'Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to manage gastric varices. However, more than one third of patients after BRTO treatment experienced worsening of esophageal varices. The present study was designed to evaluate the effect of post-BRTO propranolol adminstration on the change of esophageal varices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of liver cirrhosis\n2. Clinical diagnosis of isolated gastric varices\n3. The presenec of spontaneous portosystemic shunt\n\nExclusion Criteria:\n\n1. Contradictions to Propranolol\n2. Balloon occluded retrograde transvenous obliteration was failed'}, 'identificationModule': {'nctId': 'NCT03171805', 'briefTitle': 'The Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Post-balloon Occluded Retrograde Transvenous Obliteration Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices', 'orgStudyIdInfo': {'id': 'Propranolol in GV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propranolol group', 'description': 'Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.', 'interventionNames': ['Drug: Propranolol']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Propranolol was not given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.'}], 'interventions': [{'name': 'Propranolol', 'type': 'DRUG', 'description': 'Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.', 'armGroupLabels': ['Propranolol group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xuefeng luo', 'role': 'CONTACT', 'email': 'luo_xuefeng@yeah.net', 'phone': '02885422311'}], 'facility': 'West china Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'xuefeng luo', 'role': 'CONTACT', 'email': 'luo_xuefeng@yeah.net', 'phone': '02885422311'}], 'overallOfficials': [{'name': 'xuefeng luo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sichuan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending doctor', 'investigatorFullName': 'luo xuefeng', 'investigatorAffiliation': 'West China Hospital'}}}}