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Clinical Trials/EUCTR2005-003557-27-DE
EUCTR2005-003557-27-DE
Active, not recruiting
Not Applicable

Covered Transjugular Intrahepatic Portosystemic Stent Shunt versus Optimized medical Treatment for the Secondary Prevention of Variceal Bleeding in Cirrhosis

Dean of the Medical Faculty (University of Bonn)0 sitesNovember 21, 2005
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Conditionsliver cirrhosisesophageal (variceal) bleeding
Drugse.g. Dociton 10e.g. Dociton 40e.g. Ismo 20

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
liver cirrhosis
Sponsor
Dean of the Medical Faculty (University of Bonn)
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 21, 2005
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dean of the Medical Faculty (University of Bonn)

Eligibility Criteria

Inclusion Criteria

  • •? liver cirrhosis (histological or clinical diagnosis)
  • •? Child\-Pugh\-score \< 12
  • •? serum bilirubin \< 3 mg/dl
  • •? significant variceal bleeding \> 5 days prior to randomization
  • •? clinical indication for rebleeding prophylaxis (i.e. presence of esophageal varices ? grade 2\)
  • •? age 18 to 75 years
  • •? written informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •? overt hepatic encephalopathy independent from bleeding
  • •? prehepatic portal hypertension
  • •? type II gastric varices as exclusive bleeding site
  • •? established chronic drug treatment with betablockers and/or nitrates against portal hypertension
  • •? listing for liver transplantation on T2 status
  • •? existing portosystemic shunt (TIPS or surgical shunt)
  • •? heart failure \> NYHA 2 or ejection fraction \< 40 %
  • •? contraindication against propranolol or nitrates
  • •? platelet count \< 30 G/l, prothrombine index \< 30 %, disseminated intravascular coagulation
  • •? advanced malignancy or severe infection

Outcomes

Primary Outcomes

Not specified

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