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Completed

NCT Number: NCT01410591

TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding

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.

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Key information

Conditions

Decompensated Cirrhosis Bleeding Varices Digestive System Diseases Fibrosis Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

8-mm covered stent group

Device

Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure.

10-mm covered stent group

Device

Creating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure.

Primary outcomes

  1. Incidence of shunt dysfunction.

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Acronym: T8/10SVB

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 5, 2011
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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