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

Not Applicable

Completed

• Conditions: Decompensated Cirrhosis; Portal Hypertension; Bleeding Varices
• Interventions: Device: 10-mm covered stent group; Device: 8-mm covered stent group

• Registration Number: NCT01410591
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-05
• Study Start: 2012-07
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-23
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10-mm covered stent group	10-mm covered stent group	Patients treated with 10-mm covered stent.
8-mm covered stent group	8-mm covered stent group	Patients treated with 8-mm covered stent.

Primary Outcome Measures

Name	Time	Method
Incidence of shunt dysfunction.	2 years

Secondary Outcome Measures

Name	Time	Method
Incidence of variceal rebleeding	2 years
Incidence of hepatic encephalopathy	2 years
Survival	2 years
Incidence of hepatic myelopathy	2 years

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China