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

Cirrhosis Clinical Trial

— ENDOvsTIPS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570973
• Other study ID #: ENDOvsTIPS
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2007
• Last updated: May 20, 2011
• Start date: November 2004
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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)

• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Encephalopathy
• Gastrointestinal Hemorrhage
• Hemorrhage
• Variceal Bleeding

Intervention

Procedure:
• endoscopic band ligation
Endoscopic Band ligation of esophageal varices, performed every 2-4 weeks until resolution of varices
• TIPS-Implantation
Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent, placed once, under fluoroscopic control,

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz
Austria	Internal Medicine IV, Krankenhaus der Elisabethinen Linz	Linz	Upper Austria
Austria	Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna	Vienna
Austria	Wilhelminenspital der Stadt Wien	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of Variceal Bleeding		2 years	No
Secondary	Survival of Patients		2 years	No