Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-22 @ 1:08 PM
Study NCT ID:
NCT02468167
Status:
UNKNOWN
Last Update Posted:
2019-01-08
First Post:
2015-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004659', 'term': 'Enbucrilate'}, {'id': 'D000077423', 'term': 'Polidocanol'}], 'ancestors': [{'id': 'D003487', 'term': 'Cyanoacrylates'}, {'id': 'D000179', 'term': 'Acrylates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D014014', 'term': 'Tissue Adhesives'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2015-06-05', 'lastUpdatePostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of participants with failure to control acute bleeding or failure to prevent clinically significant variceal rebleeding within 1 year after enrollment', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': '3 years'}, {'measure': 'Eradication rate of gastric varices', 'timeFrame': '3 years'}, {'measure': 'Number of participants with increase or decrease in the size of gastric varices', 'timeFrame': '3 years'}, {'measure': 'Number of participants with appearance or worsening of new oesophageal varices', 'timeFrame': '3 years'}, {'measure': 'Number of participants with appearance or worsening of portal hypertensive gastropathy', 'timeFrame': '3 years'}, {'measure': 'Number of participants with appearance or worsening of ascites', 'timeFrame': '3 years'}, {'measure': 'Number of participants with complication', 'timeFrame': '3 years'}, {'measure': 'Average in-hospital stay', 'timeFrame': '3 years'}, {'measure': 'Cost of treatment', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastric Varices']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the management of acute gastric bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cirrhosis\n2. Active bleeding from gastric varices (GOV2 or IGV1)\n3. Presence of gastrorenal shunt\n\nExclusion Criteria:\n\n1. Previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding\n2. Previous use of TIPS or surgical shunt\n3. Non-cirrhotic portal hypertension\n4. Contraindications to cyanoacrylate injection or BRTO\n5. Portal cavernoma\n6. Hepatorenal syndrome\n7. Proven malignancy including hepatocellular carcinoma\n8. End-stage renal disease under renal replacement therapy;\n9. Cardiorespiratory failure\n10. Pregnancy or patients not giving informed consent for endoscopic procedures'}, 'identificationModule': {'nctId': 'NCT02468167', 'briefTitle': 'Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Comparison of Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration in the Management of Acute Gastric Variceal Bleeding', 'orgStudyIdInfo': {'id': 'BRTO-NBCA-AB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BRTO', 'description': 'Balloon-occluded retrograde transvenous obliteration', 'interventionNames': ['Procedure: Balloon-occluded retrograde transvenous obliteration', 'Drug: Lauromacrogol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NBCA', 'description': 'Endoscopic cyanoacrylate injection', 'interventionNames': ['Procedure: Endoscopic cyanoacrylate injection', 'Drug: N-butyl-2-cyanoacrylate']}], 'interventions': [{'name': 'Balloon-occluded retrograde transvenous obliteration', 'type': 'PROCEDURE', 'description': 'Balloon-occluded retrograde transvenous obliteration', 'armGroupLabels': ['BRTO']}, {'name': 'Endoscopic cyanoacrylate injection', 'type': 'PROCEDURE', 'description': 'Endoscopic cyanoacrylate injection', 'armGroupLabels': ['NBCA']}, {'name': 'N-butyl-2-cyanoacrylate', 'type': 'DRUG', 'armGroupLabels': ['NBCA']}, {'name': 'Lauromacrogol', 'type': 'DRUG', 'armGroupLabels': ['BRTO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuefeng Luo, MD', 'role': 'CONTACT', 'phone': '862885422389'}], 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Xufeng Luo, MD', 'role': 'CONTACT', 'email': 'luo_xuefeng@yeah.net'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'luo xuefeng', 'investigatorAffiliation': 'West China Hospital'}}}}