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临床试验/NCT03508388
NCT03508388终止不适用

Prognostic Value of Liver Volume on Acute Decompensation of Alcoholic Cirrhosis, a Prospective Multicenter Observational Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2018年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
142
试验地点
1
主要终点
All cause mortality or liver transplantation

研究概览

简要总结

Investigator seek to determine whether the volume of the liver can predict the survival after a decompensation of a patient suffering from chronic liver disease caused by excessive alcohol consumption (or alcoholic cirrhosis). Our hypothesis is that patients with a "small" liver have a lower survival compared to patients having a "normal" sized liver.

详细描述

In this observational, prospective and multicentre clinical trial, investigator seek to determine the prognostic value of liver volume during an acute decompensation. Investigator plan to enroll admitted adult patients with acute decompensation of an alcoholic cirrhosis (abstinent or not), followed for one year or until death or liver transplantation. Liver volume will be evaluated using CT-scan or MRI reconstructions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients
  • Patient suffering from alcoholic cirrhosis (withdrawn or not)
  • Patient admitted in emergency for an alcoholic cirrhosis decompensation only
  • Prescription for a cutting imaging (CT scan or MRI) during hospitalisation
  • Alcohol consumption of more than 3 units per day for men and 2 units for women in average, over at least the last 5 years before the cirrhosis diagnosis
  • Patient suffering from decompensated cirrhosis defined by at least one of the following criteria : Model For End-Stage Liver Disease (MELD) score above or equal to 15, ascites needing iterative punctures, symptomatic bacterial ou fungal infections, acute digestive bleeding due to portal hypertension, hepatic encephalopathy defined by a West Haven score above or equal to 2

排除标准

  • Nodule with typical criteria of hepatocellular carcinoma
  • B or C viral infections actives
  • Presence of transjugular intrahepatic portosystemic shunt (TIPS)
  • Presence of an occlusive thrombosis of the porta or one of the principal branches
  • Presence of a thrombosis of the sus-hepatic vein
  • Active extra-hepatic malignant tumor
  • Decompensated cardio-vascular disease
  • Patient unwilling to participate to the study

结局指标

主要结局

All cause mortality or liver transplantation

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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