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临床试验/NCT04393519
NCT04393519招募中不适用

Non-invasive Evaluation of Prognostic Parameters for Patients With Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using a Structured Follow up Protocol 2

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Survival

研究概览

简要总结

Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.

详细描述

NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Insertion of TIPS according to guidelines

排除标准

  • Contraindication for TIPS

结局指标

主要结局

Survival

时间窗: up to 10 years

death, liver transplantation

次要结局

  • Liver Failure(up to 10 years)
  • Organ Failures(up to 10 years)
  • Sarcopenia(up to 10 years)
  • Acute-on-Chronic Liver Failure (ACLF)(up to 10 years)
  • Ascites(up to 10 years)
  • Variceal Bleeding(up to 10 years)
  • Kidney Failure(up to 10 years)
  • Hepatic Encephalopathy (HE)(up to 10 years)
  • post-surgical survival(up to 10 years)

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Praktiknjo

Principal Investigator

University Hospital, Bonn

研究点 (1)

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