Clinical trial NCT00570973: Band Ligation Versus Transjugular Intrahepatic Portosystemic Stent Shunt (TIPS) in Cirrhotics With Recurrent Variceal Bleeding Non Responding to Medical Therapy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Hemorrhage
Variceal Bleeding
Cirrhosis
Encephalopathy
Keywords: Variceal Bleeding
Cirrhosis
Encephalopathy
Endoscopic band ligation
TIPS
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of Variceal Bleeding
timeFrame: 2 years
Secondary outcomes:
measure: Survival of Patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Internal Medicine IV, Krankenhaus der Elisabethinen Linz
state: Upper Austria
city: Graz
country: Austria
facility: Medical University of Graz
city: Vienna
country: Austria
facility: Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
city: Vienna
country: Austria
facility: Wilhelminenspital der Stadt Wien
Study officials:
affiliation: Medical University of Vienna
name: Arnulf Ferlitsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simonetti RG, Perricone G, Robbins HL, Battula NR, Weickert MO, Sutton R, Khan S. Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD000553. doi: 10.1002/14651858.CD000553.pub3.