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

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Portal Hypertension; Decompensated Cirrhosis; Bleeding Varices

Treatments: Device: 10-mm covered stent group; Device: 8-mm covered stent group

Study type: Interventional

Funder types: Other

Identifiers

NCT01410591

FMMU-XHDD 003 (Registry Identifier)

T8/10CSVB

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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127 participants in 2 patient groups

10-mm covered stent group

Active Comparator group

Description:

Patients treated with 10-mm covered stent.

Treatment:

Device: 10-mm covered stent group

8-mm covered stent group

Active Comparator group

Description:

Patients treated with 8-mm covered stent.

Treatment:

Device: 8-mm covered stent group