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

Phase 4

Completed

• Conditions: Gastrointestinal Hemorrhage; Variceal Bleeding; Cirrhosis; Encephalopathy
• Interventions: Procedure: endoscopic band ligation; Procedure: TIPS-Implantation

• Registration Number: NCT00570973
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-11
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-05-20
• Last Update Posted: 2011-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	endoscopic band ligation	Endoscopic Band ligation combined with medical therapy (orally, daily administered propranolol and mononitrate)
2	TIPS-Implantation	Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent

Primary Outcome Measures

Name	Time	Method
Recurrence of Variceal Bleeding	2 years

Secondary Outcome Measures

Name	Time	Method
Survival of Patients	2 years

Trial Locations

Locations (4)

Internal Medicine IV, Krankenhaus der Elisabethinen Linz; 🇦🇹 Linz, Upper Austria, Austria

Medical University of Graz; 🇦🇹 Graz, Austria

Wilhelminenspital der Stadt Wien; 🇦🇹 Vienna, Austria

Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna; 🇦🇹 Vienna, Austria