Band Ligation Versus Transjugular Intrahepatic Portosystemic Stent Shunt (TIPS) in Cirrhotics With Recurrent Variceal Bleeding Non Responding to Medical Therapy (ENDOvsTIPS)

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Encephalopathy; Cirrhosis; Variceal Bleeding; Gastrointestinal Hemorrhage

Treatments: Procedure: TIPS-Implantation; Procedure: endoscopic band ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT00570973

ENDOvsTIPS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Active Comparator group

Description:

Endoscopic Band ligation combined with medical therapy (orally, daily administered propranolol and mononitrate)

Treatment:

Procedure: endoscopic band ligation

2

Active Comparator group

Description:

Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent

Treatment:

Procedure: TIPS-Implantation