Transjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex® covered stent-graft versus endoscopic treatment for secondary prevention of gastro-oesophageal variceal bleeding

Completed

• Conditions: Gastro-oesophageal variceal bleeding; Digestive System

• Registration Number: ISRCTN77521636
• Lead Sponsor: Erasmus Medical Centre (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 124

Inclusion Criteria

1. Patients presenting with a first or second episode of oesophageal or gastric variceal bleeding, as documented by endoscopy and meeting accepted diagnostic criteria
2. Initial stabilisation (absence of evidence of continued bleeding)
3. Informed consent
4. Aged more than 18 and less than 76 years

Exclusion Criteria

1. History of serious or refractory encephalopathy, unrelated to gastrointestinal bleeding
2. History of significant heart failure (New York Heart Association [NYHA] class III & IV)
3. Portal hypertension due to other causes than liver disease (e.g. portal vein or splenic vein thrombosis)
4. Previous TIPS placement
5. Advanced hepatocellular carcinoma
6. Severely compromised liver function (Child-Pugh score greater than 13)
7. Sepsis and/or multiorgan failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified