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Immediate Listing for Liver Transplantation Versus Standard Care for Child–Pugh Stage B Alcoholic Cirrhosis: A Randomized Trial

Claire Vanlemmens, MD; Vincent Di Martino, MD, PhD; Chantal Milan, PhD; Michel Messner, MD; Anne Minello, MD, PhD; Christophe Duvoux, MD, PhD; Thierry Poynard, MD, PhD; Jean-Marc Perarnau, MD; Marie-Anne Astrid Piquet, MD, PhD; Georges-Philippe Pageaux, MD, PhD; Sébastien Dharancy, MD; Christine Silvain, MD; Sophie Hillaire, MD, PhD; Gérard Thiefin, MD; Jean-Pierre Vinel, MD; Patrick Hillon, MD; Estelle Collin, MSc; Georges Mantion, MD; Jean-Philippe Miguet, MD, the TRANSCIAL Study Group
[+] Article and Author Information

ClinicalTrials.gov registration number: NCT00701792.

For a list of the members of the TRANSCIAL (TRANSplantation for CIrrhosis related to ALcohol consumption) Study Group, see the Appendix.


From Centre Hosptialier Universitaire (CHU) Jean Minjoz, Besançon; Centre d'Epidémiologie de Population 106 and CHU du Bocage, Dijon; CHU de Pontchaillou, Rennes; CHU Henri Mondor, Créteil; CHU Pitié-Salpêtrière, Paris; Centre Hospitalier Régional Bon Secours, Metz; CHU de Caen, Caen, France; CHU Saint-Eloi, Montpellier; Centre Hospitalier Régional Universitaire Claude Huriez, Lille; CHU Jean Bernard, Poitiers; CHU Beaujon, Clichy; CHU Robert Debré, Reims; and CHU Purpan, Toulouse, France.


Note: Drs. Vanlemmens and Di Martino contributed equally to this work.

Grant Support: By the French National Program for Clinical Research.

Potential Financial Conflicts of Interest: None disclosed.

Reproducible Research Statement:Study protocol: Available at http://www.clinicaltrials.gov (NCT00701792). Statistical code and data set: Not available.

Requests for Single Reprints: Vincent Di Martino, MD, PhD, Service d'hépatologie, CHU Jean Minjoz, 3 Boulevard A. Fleming, 25030 Besançon, France; e-mail, vdimartino@chu-besancon.fr.

Current Author Addresses: Drs. Vanlemmens, Di Martino, Mantion, and Miguet and Ms. Collin: Service d'hépatologie, CHU Jean Minjoz, 3 Boulevard A. Fleming, 25030 Besançon, France.

Dr. Milan: EPI INSERM 0106, Centre d'Epidémiologie de Population, Faculté de Médecine BP 87900, 21079 Dijon, France.

Dr. Messner: Hôpital Pontchaillou, 2 rue Henri Le Guilloux, 35033 Rennes Cedex 9, France.

Drs. Minello and Hillon: CHU Le Bocage, BP 1542, 21000 Dijon Cedex, France.

Dr. Duvoux: Hôpital Henri Mondor, 51 Avenue de Lattre de Tassigny, 94010 Créteil, France.

Dr. Poynard: Hôpital Pitié-Salpêtrière, 47-83 Boulevard de l'hôpital, 75013 Paris, France.

Dr. Perarnau: CHR Metz—Hôpital Bon Secours, 1 Place Philippe De Vigneulles, 57038 Metz Cedex 1, France.

Dr. Piquet: CHRU de Caen, 14033 Caen Cedex 9, France.

Dr. Pageaux: Hôpital Saint-Eloi, 2 Avenue Bertin Sans, 34295 Montpellier, France.

Dr. Dharancy: CHU Claude Huriez, 59037 Lille, France.

Dr. Silvain: CHU Hôpital Jean Bernard, 2 Rue de la Miletrie, 86000 Poitiers, France.

Dr. Hillaire: Hôpital Beaujon, 100 Boulevard Général Leclerc, 92110 Clichy Cedex, France.

Dr. Thiefin: Hôpital Robert Debré, Avenue du Général Koenig, 51092 Reims, France.

Dr. Vienel: Hôpital Purpan, Place du Docteur Baylac, 31059 Toulouse Cedex 9, France.

Author Contributions: Conception and design: C. Vanlemmens, G. Mantion, J.P. Miguet.

Analysis and interpretation of the data: V. Di Martino, C. Milan, E. Collin.

Drafting of the article: V. Di Martino, J.P. Miguet.

Critical revision of the article for important intellectual content: C. Milan, A. Minello, T. Poynard, J.M. Perarnau, G.P. Pageaux, S. Dharancy, C. Silvain, G. Thiefin, J.P. Vinel, G. Mantion, J.P. Miguet.

Final approval of the article: C. Vanlemmens, V. Di Martino, C. Milan, M. Messner, A. Minello, C. Duvoux, T. Poynard, J.M. Perarnau, M.A. Piquet, G.P. Pageaux, S. Dharancy, C. Silvain, S. Hillaire, G. Thiefin, J.P. Vinel, P. Hillon, G. Mantion, J.P. Miguet.

Provision of study materials or patients: C. Vanlemmens, V. Di Martino, M. Messner, A. Minello, C. Duvoux, T. Poynard, J.M. Perarnau, M.A. Piquet, G.P. Pageaux, S. Dharancy, C. Silvain, S. Hillaire, G. Thiefin, J.P. Vinel, P. Hillon, G. Mantion, J.P. Miguet.

Statistical expertise: V. Di Martino, C. Milan.

Obtaining of funding: J.P. Miguet.

Administrative, technical, or logistic support: C. Vanlemmens, E. Collin.

Collection and assembly of data: C. Milan, E. Collin.


Ann Intern Med. 2009;150(3):153-161. doi:10.7326/0003-4819-150-3-200902030-00004
Text Size: A A A

Background: Liver transplantation improves survival of patients with end-stage (Child–Pugh stage C) alcoholic cirrhosis, but its benefit for patients with stage B disease is uncertain.

Objective: To compare the outcomes of patients with Child–Pugh stage B alcoholic cirrhosis who are immediately listed for liver transplantation with those of patients assigned to standard treatment with delay of transplantation until progression to stage C disease.

Design: Randomized, controlled trial.

Setting: 13 liver transplantation programs in France.

Patients: 120 patients with Child–Pugh stage B alcoholic cirrhosis and no viral hepatitis, cancer, or contraindication to transplantation.

Interventions: Patients were randomly assigned to immediate listing for liver transplantation (60 patients) or standard care (60 patients).

Measurements: Overall and cancer-free survival over 5 years.

Results: Sixty-eight percent of patients assigned to immediate listing for liver transplantation and 25% of those assigned to standard care received a liver transplant. All-cause death and cirrhosis-related death did not statistically differ between the 2 groups: 5-year survival was 58% (95% CI, 43% to 70%) for those assigned to immediate listing versus 69% (CI, 54% to 80%) for those assigned to standard care. In multivariate analysis, independent predictors of long-term survival were absence of ongoing alcohol consumption (hazard ratio, 7.604 [CI, 2.395 to 24.154]), recovery from Child–Pugh stage C (hazard ratio, 7.633 [CI, 2.392 to 24.390]), and baseline Child–Pugh score less than 8 (hazard ratio, 2.664 [CI, 1.052 to 6.746]). Immediate listing for transplantation was associated with an increased risk for extrahepatic cancer: The 5-year cancer-free survival rate was 63% (CI, 43% to 77%) for patients who were immediately listed and 94% (CI, 81% to 98%) for those who received standard care.

Limitation: Restriction of the study sample to alcoholic patients may limit the generalizability of results to other settings.

Conclusion: Immediate listing for liver transplantation did not show a survival benefit compared with standard care for Child–Pugh stage B alcoholic cirrhosis. In addition, immediate listing for transplantation increased the risk for extrahepatic cancer.

Funding: The French National Program for Clinical Research.

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Summary for Patients

Immediate Versus Later Listing for Liver Transplantation for Alcoholic Cirrhosis

The summary below is from the full report titled “Immediate Listing for Liver Transplantation Versus Standard Care for Child–Pugh Stage B Alcoholic Cirrhosis. A Randomized Trial.” It is in the 3 February 2009 issue of Annals of Internal Medicine (volume 150, pages 153-161). The authors are C. Vanlemmens, V. Di Martino, C. Milan, M. Messner, A. Minello, C. Duvoux, T. Poynard, J.M. Perarnau, M.A.A. Piquet, G.P. Pageaux, S. Dharancy, C. Silvain, S. Hillaire, G. Thiefin, J.P. Vinel, P. Hillon, E. Collin, G. Mantion, J.P. Miguet, and the TRANSCIAL Study Group.

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