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

Not Applicable

Completed

• Conditions: iver cirrhosis; Digestive System; Liver cirrhosis

• Registration Number: ISRCTN16334693
• Lead Sponsor: Individual sponsor (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-22
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Re-bleeding incidence

Secondary Outcome Measures

Name	Time	Method
1. Overall survival<br>2. Safety<br>3. Quality of life<br>4. Direct and indirect costs