Covered Transjugular Intrahepatic Portosystemic Stent Shunt versus Optimized medical Treatment for the Secondary Prevention of Variceal Bleeding in Cirrhosis

Dean of the Medical Faculty (University of Bonn)0 个研究点开始时间: 2005年11月21日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•? liver cirrhosis (histological or clinical diagnosis)
•? Child-Pugh-score < 12
•? serum bilirubin < 3 mg/dl
•? significant variceal bleeding > 5 days prior to randomization
•? clinical indication for rebleeding prophylaxis (i.e. presence of esophageal varices ? grade 2)
•? age 18 to 75 years
•? written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•? overt hepatic encephalopathy independent from bleeding
•? prehepatic portal hypertension
•? type II gastric varices as exclusive bleeding site
•? established chronic drug treatment with betablockers and/or nitrates against portal hypertension
•? listing for liver transplantation on T2 status
•? existing portosystemic shunt (TIPS or surgical shunt)
•? heart failure > NYHA 2 or ejection fraction < 40 %
•? contraindication against propranolol or nitrates
•? platelet count < 30 G/l, prothrombine index < 30 %, disseminated intravascular coagulation
•? advanced malignancy or severe infection
•? females of child bearing potential not using a safe contraceptive measure during the study or females with a positive pregnancy test prior to study or nursing women
•? patients who participated in another clinical trial in the past which may interfere with the current trial

发起方

Dean of the Medical Faculty (University of Bonn)