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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gastrointestinal Hemorrhage, Variceal Bleeding, Cirrhosis, Encephalopathy

Intervention / Treatment
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* Procedure: endoscopic band ligation
* Procedure: TIPS-Implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Endoscopic Band ligation combined with medical therapy (orally, daily administered propranolol and mononitrate) | Procedure: endoscopic band ligation<br>* Endoscopic Band ligation of esophageal varices, performed every 2-4 weeks until resolution of varices<br>|
| Active Comparator: 2<br>Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent | Procedure: TIPS-Implantation<br>* Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent, placed once, under fluoroscopic control,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Variceal Bleeding |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of Patients |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Variceal Bleeding, Cirrhosis, Encephalopathy, Endoscopic band ligation, TIPS