NCT00570973

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Hemorrhage
• Variceal Bleeding
• Cirrhosis
• Encephalopathy

Interventions

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

Timeline

• Start date: 2004-11-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2007-12-11
• Last updated: 2011-05-23

Locations

4 sites across 1 country: Austria