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Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis (TRANSCIAL)

Primary Purpose

Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
liver transplantation
standard care for liver disease
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring cirrhosis transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • cirrhosis
  • age 18-65yrs
  • Pugh B
  • written consent

Exclusion Criteria:

  • HIV, HBV or HCV infection
  • hepatocellular carcinoma
  • Pugh A or Pugh C cirrhosis
  • creatinin >200µMol/L
  • sepsis
  • psychiatric disorders
  • extrahepatic neoplasia

Sites / Locations

  • service d'hépatologie CHU jean Minjoz
  • CHRU CAEN - Service d'hépato-gastroentérologie
  • Hôpital Beaujon - Hépato-gastroentérologie
  • CHU Henri Mondor - Hépato-gastroentérologie
  • Hépato-gastroenterologie CHU Bocage
  • Centre d'épidémiologie de population EPI 106
  • Hôpital Bon secours - Hépato-gastroentérologie
  • Hôpital Saint-Eloi - Hépato-gastroentérologie
  • Hôpital Pitié-Salpétrière - Hépato-gastroentérologie
  • Hepato-gastroenterologie
  • CHU Reims - hépato-gestroentérologie
  • Clinique des maladies du foie Hôpital Pontchailloux
  • Hôpital Purpan - Hépato-gastroentérologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

surgery : liver transplantation

standard care for liver disease

Outcomes

Primary Outcome Measures

all causes mortality

Secondary Outcome Measures

Full Information

First Posted
June 5, 2008
Last Updated
June 18, 2008
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT00701792
Brief Title
Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
Acronym
TRANSCIAL
Official Title
Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
March 1994 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
cirrhosis transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
surgery : liver transplantation
Arm Title
2
Arm Type
Active Comparator
Arm Description
standard care for liver disease
Intervention Type
Procedure
Intervention Name(s)
liver transplantation
Intervention Description
liver transplantation
Intervention Type
Other
Intervention Name(s)
standard care for liver disease
Intervention 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".
Primary Outcome Measure Information:
Title
all causes mortality
Time Frame
five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cirrhosis age 18-65yrs Pugh B written consent Exclusion Criteria: HIV, HBV or HCV infection hepatocellular carcinoma Pugh A or Pugh C cirrhosis creatinin >200µMol/L sepsis psychiatric disorders extrahepatic neoplasia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Phillipe MIGUET
Organizational Affiliation
Service d'Hépatologie - CHU de Besançon
Official's Role
Study Chair
Facility Information:
Facility Name
service d'hépatologie CHU jean Minjoz
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
CHRU CAEN - Service d'hépato-gastroentérologie
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Beaujon - Hépato-gastroentérologie
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CHU Henri Mondor - Hépato-gastroentérologie
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hépato-gastroenterologie CHU Bocage
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Centre d'épidémiologie de population EPI 106
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hôpital Bon secours - Hépato-gastroentérologie
City
Metz
ZIP/Postal Code
57000
Country
France
Facility Name
Hôpital Saint-Eloi - Hépato-gastroentérologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Pitié-Salpétrière - Hépato-gastroentérologie
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hepato-gastroenterologie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU Reims - hépato-gestroentérologie
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Clinique des maladies du foie Hôpital Pontchailloux
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Hôpital Purpan - Hépato-gastroentérologie
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19189904
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.
Results Reference
derived

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Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis

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