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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2011-05-31

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.

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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.

Conditions

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Gastrointestinal Hemorrhage Variceal Bleeding Cirrhosis Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Endoscopic Band ligation combined with medical therapy (orally, daily administered propranolol and mononitrate)

Group Type ACTIVE_COMPARATOR

endoscopic band ligation

Intervention Type PROCEDURE

Endoscopic Band ligation of esophageal varices, performed every 2-4 weeks until resolution of varices

2

Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent

Group Type ACTIVE_COMPARATOR

TIPS-Implantation

Intervention Type PROCEDURE

Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent, placed once, under fluoroscopic control,

Interventions

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endoscopic band ligation

Endoscopic Band ligation of esophageal varices, performed every 2-4 weeks until resolution of varices

Intervention Type PROCEDURE

TIPS-Implantation

Transjugular intrahepatic portosystemic stent shunt with PTFE-covered stent, placed once, under fluoroscopic control,

Intervention Type PROCEDURE

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