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

Air Force Military Medical University, China127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

127

Conditions

Decompensated Cirrhosis Portal Hypertension Bleeding Varices

Interventions

8-mm covered stent groupDEVICE

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

10-mm covered stent groupDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

Incidence of shunt dysfunction.

Time frame: 2 years

Secondary Outcomes

Incidence of variceal rebleeding

Time frame: 2 years

Incidence of hepatic encephalopathy

Time frame: 2 years

Survival

Time frame: 2 years

Incidence of hepatic myelopathy

Time frame: 2 years

Data from ClinicalTrials.gov

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