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TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding (T8/10SVB)

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ClinicalTrials.gov Identifier: NCT01410591
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University

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.

Condition or disease Intervention/treatment Phase
Decompensated Cirrhosis Portal Hypertension Bleeding Varices Device: 8-mm covered stent group Device: 10-mm covered stent group Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of TIPS With 8- or 10-mm Covered Stent for Preventing Variceal Rebleeding in Cirrhotic Patients.
Study Start Date : July 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 10-mm covered stent group
Patients treated with 10-mm covered stent.
Device: 10-mm covered stent group
Creating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure.

Active Comparator: 8-mm covered stent group
Patients treated with 8-mm covered stent.
Device: 8-mm covered stent group
Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure.




Primary Outcome Measures :
  1. Incidence of shunt dysfunction. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Incidence of variceal rebleeding [ Time Frame: 2 years ]
  2. Incidence of hepatic encephalopathy [ Time Frame: 2 years ]
  3. Survival [ Time Frame: 2 years ]
  4. Incidence of hepatic myelopathy [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Sepsis
  • Spontaneous bacterial peritonitis
  • Uncontrollable hypertension
  • Serious cardiac or pulmonary dysfunction
  • Renal failure
  • Portal vein thrombosis
  • History of organ transplantation
  • History of HIV (human immunodeficiency viruses) infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410591


Locations
China, Shaanxi
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi`an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Guohong Han, PhD & MD Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Publications:
Responsible Party: Guohong Han, Head of Department of Digestive Interventional Radiology, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01410591     History of Changes
Other Study ID Numbers: T8/10CSVB
FMMU-XHDD 003 ( Registry Identifier: Fourth Military Medical University )
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by Guohong Han, Fourth Military Medical University:
transjugular intrahepatic portosystemic shunt
TIPS
liver cirrhosis
variceal bleeding
8- or 10-mm covered stent

Additional relevant MeSH terms:
Hemorrhage
Fibrosis
Hypertension, Portal
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases