CirrhosisTRANSCIALNCT00701792
Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
A study testing liver transplantation in people with Cirrhosis, run by Centre Hospitalier Universitaire de Besancon at 13 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- liver transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 13 sitesFrance
- Study dates
- Mar 1994to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cirrhosis
- age 18-65yrs
- Pugh B
- written consent
Who cannot join
- HIV, HBV or HCV infection
- hepatocellular carcinoma
- Pugh A or Pugh C cirrhosis
- creatinin >200µMol/L
- sepsis
- psychiatric disorders
- extrahepatic neoplasia
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
service d'hépatologie CHU jean Minjoz
Besançon, 25000
CHRU CAEN - Service d'hépato-gastroentérologie
Caen, 14033
Hôpital Beaujon - Hépato-gastroentérologie
Clichy, 92110
CHU Henri Mondor - Hépato-gastroentérologie
Créteil, 94010
Hépato-gastroenterologie CHU Bocage
Dijon, 21034
Centre d'épidémiologie de population EPI 106
Dijon, 21079
Hôpital Bon secours - Hépato-gastroentérologie
Metz, 57000
Hôpital Saint-Eloi - Hépato-gastroentérologie
Montpellier, 34295
Hôpital Pitié-Salpétrière - Hépato-gastroentérologie
Paris, 75013
Hepato-gastroenterologie
Poitiers, 86021
CHU Reims - hépato-gestroentérologie
Reims, 51092
Clinique des maladies du foie Hôpital Pontchailloux
Rennes, 35000
Hôpital Purpan - Hépato-gastroentérologie
Toulouse, 31059
About this study
Official title: Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
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).
Read the 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).
- Conditions
- Cirrhosis
- Being tested
- liver transplantation, standard care for liver disease
- Keywords
- cirrhosis transplantation
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver transplantationProcedure or surgery
liver transplantation
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".
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | surgery : liver transplantation Receives: Procedure: liver transplantation |
| 2 | Active comparator | standard care for liver disease Receives: Other: standard care for liver disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
all causes mortality
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startMar 1994
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Phillipe MIGUET, Study chair, Service d'Hépatologie - CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701792
- Sponsor's protocol ID
- N/1993/04
- Acronym
- TRANSCIAL
- Status last verified
- Jun 2008
- First submitted
- 5 Jun 2008
- Last updated
- 19 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19189904
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
- ClinicalTrials.gov ID
- NCT00701792
- Acronym / sponsor ID
- TRANSCIAL / N/1993/04
- Conditions
- Cirrhosis
- Keywords
- cirrhosis transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Mar 1994
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: liver transplantationsurgery : liver transplantation |
| 2 | Active comparator | Other: standard care for liver diseasestandard care for liver disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cirrhosis
- age 18-65yrs
- Pugh B
- written consent
Key exclusion criteria (7 listed)
- HIV, HBV or HCV infection
- hepatocellular carcinoma
- Pugh A or Pugh C cirrhosis
- creatinin >200µMol/L
- sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver transplantationliver transplantation | Procedure or surgery | 1 |
| standard care for liver diseasestandard 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". | Other | 2 |
Primary outcome
all causes mortality
Time frame: five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2008.
- Derived from this study: PubMed 19189904Vanlemmens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Phillipe MIGUET study chair
Service d'Hépatologie - CHU de Besançon
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liver transplantation in people with Cirrhosis, run by Centre Hospitalier Universitaire de Besancon at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all causes mortality (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00701792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2008; AzTrials last refreshed its copy on 7 Nov 2026.