NCT00701792

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 1994

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1994

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
Last Updated

June 19, 2008

Status Verified

June 1, 2008

Enrollment Period

12.7 years

First QC Date

June 5, 2008

Last Update Submit

June 18, 2008

Conditions

Cirrhosis

Keywords

cirrhosis transplantation

Outcome Measures

Primary Outcomes (1)

  • all causes mortality

    five years

Study Arms (2)

1

ACTIVE COMPARATOR

surgery : liver transplantation

Procedure: liver transplantation

2

ACTIVE COMPARATOR

standard care for liver disease

Other: standard care for liver disease

Interventions

liver transplantationPROCEDURE

liver transplantation

1
standard care for liver diseaseOTHER

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".

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

service d'hépatologie CHU jean Minjoz

Besançon, 25000, France

Location

CHRU CAEN - Service d'hépato-gastroentérologie

Caen, 14033, France

Location

Hôpital Beaujon - Hépato-gastroentérologie

Clichy, 92110, France

Location

CHU Henri Mondor - Hépato-gastroentérologie

Créteil, 94010, France

Location

Hépato-gastroenterologie CHU Bocage

Dijon, 21034, France

Location

Centre d'épidémiologie de population EPI 106

Dijon, 21079, France

Location

Hôpital Bon secours - Hépato-gastroentérologie

Metz, 57000, France

Location

Hôpital Saint-Eloi - Hépato-gastroentérologie

Montpellier, 34295, France

Location

Hôpital Pitié-Salpétrière - Hépato-gastroentérologie

Paris, 75013, France

Location

Hepato-gastroenterologie

Poitiers, 86021, France

Location

CHU Reims - hépato-gestroentérologie

Reims, 51092, France

Location

Clinique des maladies du foie Hôpital Pontchailloux

Rennes, 35000, France

Location

Hôpital Purpan - Hépato-gastroentérologie

Toulouse, 31059, France

Location

Related Publications (1)

  • 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.

    PMID: 19189904DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Liver TransplantationStandard of Care

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantationQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jean-Phillipe MIGUET

    Service d'Hépatologie - CHU de Besançon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 19, 2008

Study Start

March 1, 1994

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

June 19, 2008

Record last verified: 2008-06

Locations

FR(13)