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Clinical Trials/ISRCTN16334693
ISRCTN16334693
Completed
未知

Covered transjugular intrahepatic portosystemic stent shunt versus optimised medical treatment for the secondary prevention of variceal bleeding in cirrhosis

Individual sponsor (Germany)0 sites186 target enrollmentMarch 22, 2006
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Individual sponsor (Germany)
Enrollment
186
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 22, 2006
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Individual sponsor (Germany)

Eligibility Criteria

Inclusion Criteria

  • •1\. Liver cirrhosis (histological or clinical diagnosis)
  • •2\. Child\-Pugh score less than 12
  • •3\. Serum bilirubin less than 3 mg/dl
  • •4\. Significant variceal bleeding greater than 5 days prior to randomisation
  • •5\. Clinical indication for re\-bleeding prophylaxis (i.e. presence of esophageal varices greater than or equal to grade 2\)
  • •6\. Age 18 to 75
  • •7\. Written informed consent signed and dated by patient and investigator

Exclusion Criteria

  • •1\. Overt hepatic encephalopathy independent from bleeding
  • •2\. Pre\-hepatic portal hypertension
  • •3\. Type II gastric varices as exclusive bleeding site
  • •4\. Established chronic drug treatment with beta\-blockers and/or nitrates against portal hypertension
  • •5\. Listing for liver transplantation on T2 status
  • •6\. Existing porto\-systemic shunt (TIPS or surgical shunt)
  • •7\. Heart failure according to the New York Heart Association (NYHA) classification greater than 2 or ejection fraction less than 40%
  • •8\. Contraindication against propanolol or nitrates
  • •9\. Platelet count less than 30 g/l, prothrombin index less than 30%, disseminated intravascular coagulation
  • •10\. Advanced malignancy or severe infection

Outcomes

Primary Outcomes

Not specified

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