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

This study is currently recruiting participants.
Verified July 2012 by Fourth Military Medical University
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01410591
First received: August 4, 2011
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Decompensated Cirrhosis
Portal Hypertension
Bleeding Varices
 Device: 8-mm covered stent group
Device: 10-mm covered stent group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • Incidence of shunt dysfunction. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of variceal rebleeding [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Incidence of hepatic encephalopathy [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • Incidence of hepatic myelopathy [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410591

Contacts
Contact: Ming Bai, MD 86-29-84771528 ccckycdgd@yahoo.com.cn

Locations
China, Shaanxi
Xijing Hospital of Digestive Diseases, Fourth Military Medical University Recruiting
Xi`an, Shaanxi, China, 710032
Contact: Guohong Han, MD     86-29-84771528     hangh@fmmu.edu.cn    
Contact: Ming Bai, MD     86-29-84771528     ccckycdgd@yahoo.com.cn    
Principal Investigator: Guohong Han, PhD & MD            
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Guohong Han, PhD & MD Xijing Hospital of Digestive Diseases, Fourth Military Medical University
  More Information

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
Study First Received: August 4, 2011
Last Updated: July 2, 2012
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 19, 2013