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Transjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex covered stent-graft versus endoscopic treatment for acute bleeding of esophageal varices.

Recruiting
Conditions
bleeding of esophageal varicose veins
portal hypertension
10019654
Registration Number
NL-OMON39467
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
72
Inclusion Criteria

Acute or subacute bleeding of esophageal varices as documented with diagnostic endoscopy.
Initial stabilization, as achieved by using octreotide infusion and endoscopic ligation of the major bleeding vessel, and placement of a Sengstaken tube in patients in whom the former combination treatment fails to stop the bleeding.
Informed consent.

Exclusion Criteria

Serious or untreatable encephalopathy.
Heart failure.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Recurrence of bleeding</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Initial technical success in staunching bleeding.<br /><br>Child Pugh classification.<br /><br>Incidence of encephalopathy.<br /><br>Mortality.<br /><br>Medical costs.<br /><br>Non-medical costs.</p><br>
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