Covered transjugular intrahepatic portosystemic stent shunt versus optimised medical treatment for the secondary prevention of variceal bleeding in cirrhosis

Individual sponsor (Germany)0 个研究点目标入组 186 人开始时间: 2006年3月22日最近更新: 2017年7月24日

试验速览

暂无简介。

•1. Liver cirrhosis (histological or clinical diagnosis)
•2. Child-Pugh score less than 12
•3. Serum bilirubin less than 3 mg/dl
•4. Significant variceal bleeding greater than 5 days prior to randomisation
•5. Clinical indication for re-bleeding prophylaxis (i.e. presence of esophageal varices greater than or equal to grade 2)
•6. Age 18 to 75
•7. Written informed consent signed and dated by patient and investigator

•1. Overt hepatic encephalopathy independent from bleeding
•2. Pre-hepatic portal hypertension
•3. Type II gastric varices as exclusive bleeding site
•4. Established chronic drug treatment with beta-blockers and/or nitrates against portal hypertension
•5. Listing for liver transplantation on T2 status
•6. Existing porto-systemic shunt (TIPS or surgical shunt)
•7. Heart failure according to the New York Heart Association (NYHA) classification greater than 2 or ejection fraction less than 40%
•8. Contraindication against propanolol or nitrates
•9. Platelet count less than 30 g/l, prothrombin index less than 30%, disseminated intravascular coagulation
•10. Advanced malignancy or severe infection
•11. 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

发起方

Individual sponsor (Germany)