Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-06 @ 7:57 AM
Study NCT ID:
NCT00701792
Status:
COMPLETED
Last Update Posted:
2008-06-19
First Post:
2008-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-18', 'studyFirstSubmitDate': '2008-06-05', 'studyFirstSubmitQcDate': '2008-06-18', 'lastUpdatePostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all causes mortality', 'timeFrame': 'five years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cirrhosis transplantation'], 'conditions': ['Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '19189904', 'type': 'DERIVED', 'citation': 'Vanlemmens C, Di Martino V, Milan C, Messner M, Minello A, Duvoux C, Poynard T, Perarnau JM, Piquet MA, Pageaux GP, Dharancy S, Silvain C, Hillaire S, Thiefin G, Vinel JP, Hillon P, Collin E, Mantion G, Miguet JP; TRANSCIAL Study Group. Immediate listing for liver transplantation versus standard care for Child-Pugh stage B alcoholic cirrhosis: a randomized trial. Ann Intern Med. 2009 Feb 3;150(3):153-61. doi: 10.7326/0003-4819-150-3-200902030-00004.'}]}, 'descriptionModule': {'briefSummary': 'Liver transplantation has been universally recognized to improve survival of patients suffering from end-stage (Pugh C) alcoholic cirrhosis. However, for Pugh B patients, the benefit of liver transplantation remains to be demonstrated. The aim of the present study was to compare the outcome of Pugh B patients with alcoholic cirrhosis randomly assigned for immediate liver transplantation (group 1) or standard treatments (group 2).', 'detailedDescription': '120 patients (60 per group) were included. The therapeutic strategy defined by randomization was achieved in 68% of group 1 patients and 75% of group 2 patients (NS). All-causes death and cirrhosis-related death were not different in group 1 and group 2 patients: the five-year survival rate was 58% in group 1 and 69% in group 2 patients (NS). Through multivariate analysis, the independent predictors of long-term survival were absence of ongoing alcohol consumption (p\\<0.001), recovery from Pugh C (p=0.046), and baseline Pugh score\\<8 (p=0.029). Liver transplantation was associated with a higher rate of de novo malignancies (30.4% vs. 7.8%, OR=5.1, p=0.001).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cirrhosis\n* age 18-65yrs\n* Pugh B\n* written consent\n\nExclusion Criteria:\n\n* HIV, HBV or HCV infection\n* hepatocellular carcinoma\n* Pugh A or Pugh C cirrhosis\n* creatinin \\>200µMol/L\n* sepsis\n* psychiatric disorders\n* extrahepatic neoplasia'}, 'identificationModule': {'nctId': 'NCT00701792', 'acronym': 'TRANSCIAL', 'briefTitle': 'Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis', 'orgStudyIdInfo': {'id': 'N/1993/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'surgery : liver transplantation', 'interventionNames': ['Procedure: liver transplantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'standard care for liver disease', 'interventionNames': ['Other: standard care for liver disease']}], 'interventions': [{'name': 'liver transplantation', 'type': 'PROCEDURE', 'description': 'liver transplantation', 'armGroupLabels': ['1']}, {'name': 'standard care for liver disease', 'type': 'OTHER', 'description': 'standard care for liver disease included therapy for ascitis (spironolactone, furosemide), portal hypertension (oesophageal varices ; propranolol), encephalopathy (lactulose), and bacterial infections whatever their localization (prophylaxis of spontaneous peritonitis with norfloxacin). All medical or instrumental procedures were allowed. Patients undergoing iterative paracentesis, variceal band ligation or sclerotherapy, peritoneojugular shunt (LeVeen), transjugular intrahepatic portosystemic shunt (TIPS) or surgical portocaval anastomosis were considered as receiving "standard medical therapy".', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': "service d'hépatologie CHU jean Minjoz", 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': "CHRU CAEN - Service d'hépato-gastroentérologie", 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Hôpital Beaujon - Hépato-gastroentérologie', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'CHU Henri Mondor - Hépato-gastroentérologie', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21034', 'city': 'Dijon', 'country': 'France', 'facility': 'Hépato-gastroenterologie CHU Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': "Centre d'épidémiologie de population EPI 106", 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '57000', 'city': 'Metz', 'country': 'France', 'facility': 'Hôpital Bon secours - Hépato-gastroentérologie', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Saint-Eloi - Hépato-gastroentérologie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié-Salpétrière - Hépato-gastroentérologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Hepato-gastroenterologie', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'CHU Reims - hépato-gestroentérologie', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Clinique des maladies du foie Hôpital Pontchailloux', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Purpan - Hépato-gastroentérologie', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Jean-Phillipe MIGUET', 'role': 'STUDY_CHAIR', 'affiliation': "Service d'Hépatologie - CHU de Besançon"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': "M. FLAMMARION - Directeur des Projets, de la Recherche CLinique et de l'Innovation", 'oldOrganization': 'Centre Hospitalier Universitaire de Besancon'}}}}