Validation of an Accelerated Procedure of Selection in Early Liver Transplantation for Severe Alcoholic Hepatitis Not Responding to Medical Treatment QuickTransHAA.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 试验地点
- 45
- 主要终点
- Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.
研究概览
简要总结
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
详细描述
Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/
- •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
排除标准
- 未提供
结局指标
主要结局
Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.
时间窗: 2 years
Aim is to demonstrate that alcohol relapse within the 2-year follow-up period in patients selected for early liver transplantation for severe alcoholic hepatitis is not inferior to that of patients transplanted for alcoholic cirrhosis using the 6-month sobriety period.
次要结局
- Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis(2 years)
- Reproducibility of an algorithm of selection for candidates to liver transplantation(2 years)
- Incidence of alcohol relapse(2 years)
- Pattern of alcohol relapse in the two groups of transplanted patients(2 years)