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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01410591

Acronym

T8/10SVB

Enrollment

127

Registered

2011-08-05

Start date

2012-07-31

Completion date

2016-01-31

Last updated

2016-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding Varices, Decompensated Cirrhosis, Portal Hypertension

Keywords

transjugular intrahepatic portosystemic shunt, TIPS, liver cirrhosis, variceal bleeding, 8- or 10-mm covered stent

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.

Interventions

DEVICE8-mm covered stent group

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

DEVICE10-mm covered stent group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of shunt dysfunction.	2 years

Secondary

Measure	Time frame
Incidence of variceal rebleeding	2 years
Incidence of hepatic encephalopathy	2 years
Survival	2 years
Incidence of hepatic myelopathy	2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026