Transjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex(R) covered stent-graft versus endoscopic treatment for secondary prevention of gastro-esophageal variceal bleeding.
- Conditions
- TIPS, endoscopic treatment, variceal bleeding(TIPS, endoscopische behandeling, varices bloedingen)
- Registration Number
- NL-OMON21706
- Lead Sponsor
- Erasmus MC, department of Radiology and Department of Gastro-enterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
1. Patients presenting with a first or second episode of esophageal or gastric variceal bleeding, as documented by endoscopy and meeting accepted diagnostic criteria;
2. Initial stabilization (absence of evidence of continued bleeding);
3. Informed consent;
4. Age > 18 and < 76 years
Exclusion Criteria
1. History of serious or refractory encephalopathy, unrelated to gastrointestinal bleeding;
2. History of significant heart failure (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 >13);
7. Sepsis and/or multiorgan failure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence of variceal bleeding
- Secondary Outcome Measures
Name Time Method 1. Occurrence of treatment failure (either switch to other therapy -cross-over”- or death);<br>2. Incidence of encephalopathy, defined as occurrence of grade II, III or IV encephalopathy;<br>3. Liver function (according to Child-Pugh class); <br>4. Mortality;<br>5. Quality of life; <br>6. Costs