Cirrhosis, Encephalopathy, Gastrointestinal Hemorrhage, Variceal Bleeding
Conditions
Keywords
Variceal Bleeding, Cirrhosis, Encephalopathy, Endoscopic band ligation, TIPS
Brief summary
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.
Detailed description
Reduction of portal pressure are with oral intake of non selective beta blockers, often combined with mononitrates are the method of choice in secondary prophylaxis of esophageal variceal bleeding. However, studies have shown that this therapy is effective only in 20-50% of the patients, documented by a significant drop of the portal pressure with hepatic venous pressure (HVPG) measurements. The best method for secondary prevention in this high risk patient cohort is not known so far. In this randomized controlled study we hypothesise, that a group of 20 vs 20 patients is large enough to discriminate efficacy of prevention of rebleeding in patients receiving TIPS implantation or endoscopic band ligation in patients non responding to medical therapy as secondary prophylaxis of esophageal variceal bleeding.
Interventions
Endoscopic Band ligation of esophageal varices, performed every 2-4 weeks until resolution of varices
Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent, placed once, under fluoroscopic control,
Sponsors
Study design
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) *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of Variceal Bleeding | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Survival of Patients | 2 years |
Countries
Austria