Cirrhosis Clinical Trial
— ENDOvsTIPSOfficial title:
A Randomized, Controlled, Multicentric Trial Comparing Endoscopic Band Ligation Versus Ransjugular Intrahepatic Portosystemic Stent Shunt in Cirrhotic Patients With Recurrent Variceal Bleeding Non Responding to Medical Therapy
Verified date | May 2011 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Ethikkommission |
Study type | Interventional |
Patients with liver cirrhoses and recent history of variceal bleeding, with HVPG documented non response to medical therapy with non selective beta blockers +/- mononitrates or variceal rebleeding during adequate medical therapy will be randomized to undergo either multi-session endoscopic multi-band ligation and continuation of medication or TIPS placement. Best treatment for this group of cirrhotic patients is not known so far.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - liver cirrhosis - bleeding from esophageal varices within the last 6 months - sufficient medical therapy (at least 80 mg propranolol per day) - signed written informed consent Exclusion Criteria: - bleeding of gastric varices - portal vein thrombosis - insufficient medical therapy (less than 80 mg propranolol per day) - exclusion criteria for TIPS/band ligation (anatomy, impaired coagulation parameters, severe encephalopathy, severe liver failure (bilirubin > 10 mg/dl)) congestive heart failure, pulmonary hypertension, polycystic liver disease, presence or suspicion of active systemic, biliary or ascitic fluid infection, known cavernous portal vein occlusion - Budd Chiari syndrome |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Graz | Graz | |
Austria | Internal Medicine IV, Krankenhaus der Elisabethinen Linz | Linz | Upper Austria |
Austria | Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna | Vienna | |
Austria | Wilhelminenspital der Stadt Wien | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of Variceal Bleeding | 2 years | No | |
Secondary | Survival of Patients | 2 years | No |
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