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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Hypertension
Hypertension, Portal
Liver Cirrhosis
Cardiovascular Diseases
Digestive System Diseases
Liver Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014