Applicability of Liver Transplantation in Alcoholic Hepatitis
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 17
- 主要终点
- Evaluate survival of patients with severe alcoholic hepatitis non responsive to therapy after liver transplantation
研究概览
简要总结
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.
详细描述
This is a open prospective multicenter study. Nineteen liver transplant units in Spain will take part in it.
Inclusion criteria for patients:
- 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
Exclusion criteria :
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Evaluate survival of patients with severe alcoholic hepatitis non responsive to therapy after liver transplantation
时间窗: 1 year after the diagnosis of alcoholic hepatitis
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
次要结局
- 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)