CompletedNot Applicable

Validation of the Procedure of Early Liver Transplantation in Alcoholic Hepatitis Resisting to Medical Treatment

Belgium, France284 participantsStarted 2012-12-05

Plain-language summary

The purpose of this study is to validate a strategy of identification of patients for early liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. N Engl J Med 2011) that liver transplantation may be an option in very carefully selected patients who did not respond to medical treatment. This selection process deserves to be confirmed in a population of greater size. We hypothesized that patients selected with this process would have a same alcohol relapse rate after liver transplantation than patients transplanted for alcoholic cirrhosis and selected using a 6-month sobriety period

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (Group A): * Age \> 18 years * Maddrey score \> 32 * Liver biopsy confirming the diagnosis of alcoholic hepatitis * Non-response to medical treatment: Lille score ≥ 0.45 at day 7, or early worsening of liver function (MELD score \> 25) despite a low Lille score (\< 0.45) * Hospitalization stay \< 1 month * Algorithm score ≥ 220/250. Inclusion Criteria (Group B): * Age \>18 years * Diagnosis of alcoholic cirrhosis * Alcoholic withdrawal of 6 months minimum before inscription on the transplant list * MELD score ≥ 15 for patients with hepatocellular carcinoma responding to Milan criteria (1 node \< 5 cm or 3 nodes \< 3 cm) * MELD score ≥ 20 preferably for patients not displaying hepatocellular carcinoma and that did not obtain an "expert" component * No recommendation of MELD score for patients having obtained an "expert" component Non-inclusion Criteria (Group A and B): * Bacterial or viral infection uncontrolled by medical treatment * Fungal or aspergillosis uncontrolled infection * Hepatocellular carcinoma or invasive cancer * Positive test for HBsAg, Positive test for HIV,Positive PCR for HCV * Portal thrombosis * Pregnancy or breast-feeding woman

What they're measuring

Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.

Timeframe: 2 years

Trial details

NCT IDNCT01756794

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-07