Liver Transplantation in Alcoholic Hepatitis

NCT01768715 | Suspended

• 1 other identifier: SETH-HA
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 17

Brief Summary

Patients with alcoholic hepatitis non-responsive to steroids have a poor prognosis. Recently a French-Belgian prospective study has obtained good results (acceptable survival with a low rate of alcohol recidivism). The hypothesis of the present study is that carefully selected Spanish patients with alcoholic hepatitis that do not respond to steroid therapy may have a good survival if they receive a liver transplant. The expected rate of alcohol recidivism in such a selected population will be low.

Conditions

Alcoholic Hepatitis

Keywords

Alcoholic hepatitis; Liver transplantation; Survival; Alcoholism

Outcome Measures

Primary Outcomes (1)

• Evaluate survival of patients with severe alcoholic hepatitis non responsive to therapy after liver transplantation

  The survival of patients transplanted with alcoholic hepatitis is going to be compared with the survival of patients with alcoholic hepatitis that are not considered adequate for liver transplantation

  1 year after the diagnosis of alcoholic hepatitis

Secondary Outcomes (4)

• Evaluate the applicability of liver transplantation in patients with alcoholic hepatitis non responsive to steroid therapy

  1 year

• Evaluate the mortality in waiting list for transplantation of patients with alcoholic hepatitis unresponsive to steroid therapy

  1 year

• Evaluate the rate of alcohol recidivism after liver transplantation for alcoholic hepatitis

  1, 2, 3, 4 and 5 years

• Evaluate survival of patients with alcoholic hepatitis after liver transplantation.

  2, 3, 4 and 5 years after the diagnosis of alcoholic hepatitis

Study Arms (3)

Good response

Patients with severe alcoholic hepatitis and good response to therapy.

Non transplant candidates

Patients with severe alcoholic hepatitis and poor response to therapy, that are not candidates to transplantation, according to the specified criteria.

Transplant candidates

Patients with severe alcoholic hepatitis and poor response to therapy, that are candidates to transplantation, according to the specified criteria.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with alcoholic hepatitis participating in this trial are going to be selected from patients admitted to the hospital (from the emergency department or referred from other hospital)

You may qualify if:

• Diagnosis of alcoholic hepatitis (liver biopsy will be advisable).
• First episode of clinical decompensation of alcoholic liver disease (defined as jaundice, variceal bleeding, ascites or portal-systemic encephalopathy).
• Absence of a high risk of alcoholic recidivism (according to De Gottardi, et al).
• Severe alcoholic hepatitis (ABIC score \> 6.71)
• Informed consent

You may not qualify if:

• Age over 65 years.
• Hepatitis B or C or HIV infections.
• Uncontrolled bacterial infection
• Other liver diseases, such as alpha-1-antitrypsin deficiency, primary biliary cirrhosis, ...
• Morbid obesity (BMI \> 35 kg/m2)
• Major uncontrolled psychiatric disease
• Drug addiction (excluding tobacco) in the last two years.
• Absence of informed consent.
• Acute-on-chronic liver disease.
• Paracetamol consumption over 10 grams in the last week.
• Criteria for liver transplantation.
• Absence of response to steroid therapy (Lille score ≥ 0.45 7 days after initiation of steroid therapy).
• Adequate social and familiar environment.
• Complete agreement in the medical staff about the candidate to transplantation.
• Absence of bacterial or fungal infection.

Sponsors & Collaborators

• Sociedad Española de Trasplante Hepático: lead
• Fundación Mutua Madrileña: collaborator

Study Sites (17)

Hospital Vall d'Hebrón

Barcelona, Barcelona, Spain

Location

Hospital Marqués de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Reina Sofía

Córdoba, Córdoba, Spain

Location

Hospital Virgen de la Nieves

Granada, Granada, Spain

Location

Complejo Hospitalario Universitario de la Coruña

A Coruña, La Coruña, Spain

Location

Hospital Clínico Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

Location

Hospital Gregorio Marañón

Madrid, Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Murcia, Spain

Location

Hospital Carlos Haya

Málaga, Málaga, Spain

Location

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Location

Hospital Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital Virgen del Rocío

Seville, Sevilla, Spain

Location

Hospital La Fe

Valencia, Valencia, Spain

Location

Hospital Río Hortega

Valladolid, Valladolid, Spain

Location

Hospital Lozano Blesa

Zaragoza, Zaragoza, Spain

Location

Related Publications (4)

• Dominguez M, Rincon D, Abraldes JG, Miquel R, Colmenero J, Bellot P, Garcia-Pagan JC, Fernandez R, Moreno M, Banares R, Arroyo V, Caballeria J, Gines P, Bataller R. A new scoring system for prognostic stratification of patients with alcoholic hepatitis. Am J Gastroenterol. 2008 Nov;103(11):2747-56. doi: 10.1111/j.1572-0241.2008.02104.x. Epub 2008 Aug 21.

  PMID: 18721242 BACKGROUND

• Tome S, Martinez-Rey C, Gonzalez-Quintela A, Gude F, Brage A, Otero E, Abdulkader I, Forteza J, Bustamante M, Varo E. Influence of superimposed alcoholic hepatitis on the outcome of liver transplantation for end-stage alcoholic liver disease. J Hepatol. 2002 Jun;36(6):793-8. doi: 10.1016/s0168-8278(02)00047-8.

  PMID: 12044530 BACKGROUND

• Wells JT, Said A, Agni R, Tome S, Hughes S, Dureja P, Lucey MR. The impact of acute alcoholic hepatitis in the explanted recipient liver on outcome after liver transplantation. Liver Transpl. 2007 Dec;13(12):1728-35. doi: 10.1002/lt.21298.

  PMID: 18044757 BACKGROUND

• Mathurin P, Moreno C, Samuel D, Dumortier J, Salleron J, Durand F, Castel H, Duhamel A, Pageaux GP, Leroy V, Dharancy S, Louvet A, Boleslawski E, Lucidi V, Gustot T, Francoz C, Letoublon C, Castaing D, Belghiti J, Donckier V, Pruvot FR, Duclos-Vallee JC. Early liver transplantation for severe alcoholic hepatitis. N Engl J Med. 2011 Nov 10;365(19):1790-800. doi: 10.1056/NEJMoa1105703.

  PMID: 22070476 BACKGROUND

MeSH Terms

Conditions

Hepatitis, Alcoholic; Alcoholism

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ignacio Herrero, MD

  Clinica Universidad de Navarra

  STUDY CHAIR

• Santiago Tome, MD

  Complejo Hospitalario Universitario de Santiago

  STUDY CHAIR

• Ignacio Gonzalez-Pinto, MD

  Hospital Central de Asturias

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2012
• First Posted: January 15, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2017
• Last Updated: June 3, 2014

Record last verified: 2014-06

Locations

ES (17)