Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-27 @ 9:09 AM
Study NCT ID:
NCT01370161
Status:
COMPLETED
Last Update Posted:
2019-01-17
First Post:
2011-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019168', 'term': 'Portasystemic Shunt, Transjugular Intrahepatic'}], 'ancestors': [{'id': 'D011170', 'term': 'Portasystemic Shunt, Surgical'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-15', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of survival without liver transplantation', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year', 'timeFrame': '1 years'}, {'measure': 'Number of bleeding related death', 'timeFrame': '2 years'}, {'measure': 'Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy)', 'timeFrame': '2 years'}]}, 'conditionsModule': {'keywords': ['transjugular intrahepatic portosystemic shunt', 'TIPS', 'variceal bleeding', 'liver cirrhosis', 'hepatitis B'], 'conditions': ['Decompensated Cirrhosis', 'Bleeding Varices']}, 'referencesModule': {'references': [{'pmid': '20573925', 'type': 'BACKGROUND', 'citation': 'Garcia-Pagan JC, Caca K, Bureau C, Laleman W, Appenrodt B, Luca A, Abraldes JG, Nevens F, Vinel JP, Mossner J, Bosch J; Early TIPS (Transjugular Intrahepatic Portosystemic Shunt) Cooperative Study Group. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med. 2010 Jun 24;362(25):2370-9. doi: 10.1056/NEJMoa0910102.'}, {'pmid': '31153882', 'type': 'DERIVED', 'citation': 'Lv Y, Yang Z, Liu L, Li K, He C, Wang Z, Bai W, Guo W, Yu T, Yuan X, Zhang H, Xie H, Yao L, Wang J, Li T, Wang Q, Chen H, Wang E, Xia D, Luo B, Li X, Yuan J, Han N, Zhu Y, Niu J, Cai H, Xia J, Yin Z, Wu K, Fan D, Han G; AVB-TIPS Study Group. Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial. Lancet Gastroenterol Hepatol. 2019 Aug;4(8):587-598. doi: 10.1016/S2468-1253(19)30090-1. Epub 2019 May 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether early use of transjugular intrahepatic portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to prolong the survival in patients with advanced cirrhosis and acute variceal bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of cirrhosis (clinical or by liver biopsy)\n* Admission due to acute bleeding from oesophageal or gastric (GOV1 or GOV2) varices\n* Child-Pugh Class C (Child-Pugh score less than or equal to 13) or Child-Pugh class B\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Patients not fulfilling inclusion criteria\n* Pregnancy or breast-feeding\n* Confirmed hepatocellular carcinoma\n* Creatinine greater than 3 mg/dl\n* Terminal hepatic failure (Child-Pugh score greater than 13)\n* Previous treatment with TIPS or combined pharmacological and endoscopic treatment to prevent rebleeding\n* Fundal or ectopic gastric variceal bleeding (IGV1 or IGV2)\n* Complete portal vein thrombosis or portal cavernoma\n* Congestive heart failure New York Heart Association (NYHA) greater than III or medical history of pulmonary hypertension\n* Spontaneous recurrent hepatic encephalopathy'}, 'identificationModule': {'nctId': 'NCT01370161', 'briefTitle': 'Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Early Transjugular Intrahepatic Portosystemic Shunt With Polytetrafluoroethylene Covered Stents Versus Standard Medical Therapy for Acute Variceal Bleeding in Patients With Advanced Cirrhosis', 'orgStudyIdInfo': {'id': 'XHDD 002'}, 'secondaryIdInfos': [{'id': 'FMMU-XHDD 002', 'type': 'REGISTRY', 'domain': 'Fourth Military Medical University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIPS treatment', 'description': 'Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.TIPS will be performed as soon as possible once the patients are enrolled in the study, always within the first 72 hours after the diagnostic endoscopy (preferably in the first 24 hours).Vasoactive drugs will be continued until the TIPS is performed and antibiotics will be continued for 5-7 days.', 'interventionNames': ['Procedure: TIPS treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medical treatment', 'description': 'Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.Patients will be treated with non-selective beta-blockers (propranolol)on day 5. In case of contraindications or intolerance to beta-blockers, patients will not receive pharmacological treatment (beta-blockers) and the only treatment to prevent rebleeding will be endoscopic band ligation.', 'interventionNames': ['Drug: Medical treatment']}], 'interventions': [{'name': 'TIPS treatment', 'type': 'PROCEDURE', 'otherNames': ['Transjugular intrahepatic portosystemic shunt (TIPS)'], 'description': '1. A 8 mm Fluency stent will be used. The aim will be to reduce the portal pressure gradient (PPG) below to 12 mm Hg or 25-75% of baseline.\n2. Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices.\n3. After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted.', 'armGroupLabels': ['TIPS treatment']}, {'name': 'Medical treatment', 'type': 'DRUG', 'otherNames': ['Non-selective beta blocker + Endoscopic variceal ligation'], 'description': 'Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (propranolol) will be started with an initial dose of 40 mg, the dose of propranolol will be increased/decreased step by step to achieve a baseline heart rate of 55 bpm, or 25% reduction of basal heart rate or up to the maximum tolerated dose of propranolol.\n\nThe second elective session of endoscopic band ligation will be performed within the first 7-14 days after the initial endoscopic treatment. The following sessions will be performed at 14 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new band ligation will be performed.', 'armGroupLabels': ['Medical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital of Digestive Diseases, Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Guohong Han, PhD & MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital of Digestive Diseases, Fourth Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Digestive Interventional Radiology', 'investigatorFullName': 'Guohong Han', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}