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Clinical Trials/NCT01410591
NCT01410591
Completed
Not Applicable

The Effect of TIPS With 8- or 10-mm Covered Stent for Preventing Variceal Rebleeding in Cirrhotic Patients.

Air Force Military Medical University, China1 site in 1 country127 target enrollmentJuly 2012
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ConditionsDecompensated CirrhosisPortal HypertensionBleeding Varices

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Decompensated Cirrhosis
Sponsor
Air Force Military Medical University, China
Enrollment
127
Locations
1
Primary Endpoint
Incidence of shunt dysfunction.
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal bleeding.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
January 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Air Force Military Medical University, China
Responsible Party
Principal Investigator
Principal Investigator

Guohong Han

Head of Department of Digestive Interventional Radiology

Air Force Military Medical University, China

Eligibility Criteria

Inclusion Criteria

  • •Cirrhotic patients with at least one episode of variceal bleeding
  • •No active bleeding within 5 days before TIPS
  • •Child-Pugh score ≤13
  • •Signed written informed consent

Exclusion Criteria

  • •An age \<18 years or \>75 years
  • •With TIPS contraindications
  • •Past or present history of hepatic encephalopathy
  • •Pregnancy or breast-feeding
  • •Hepatic carcinoma and/or other malignancy diseases
  • •Spontaneous bacterial peritonitis
  • •Uncontrollable hypertension
  • •Serious cardiac or pulmonary dysfunction
  • •Renal failure
  • •Portal vein thrombosis

Outcomes

Primary Outcomes

Incidence of shunt dysfunction.

Time Frame: 2 years

Secondary Outcomes

  • Incidence of hepatic myelopathy(2 years)
  • Incidence of variceal rebleeding(2 years)
  • Incidence of hepatic encephalopathy(2 years)
  • Survival(2 years)

Study Sites (1)

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