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

• Conditions: liver cirrhosis; esophageal (variceal) bleeding

• Registration Number: EUCTR2005-003557-27-DE
• Lead Sponsor: Dean of the Medical Faculty (University of Bonn)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-21
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

? 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

Exclusion Criteria

? 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: rebleeding incidence;Secondary Objective: overall survival, safety, quality of life and direct and indirect costs, side effects, complications;Primary end point(s): rebleeding