TIPS vs Endoscopic Therapy for Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Liver Cirrhosis; Portal Vein Thrombosis

Treatments: Procedure: Transjugular intrahepatic portosystemic shunt; Procedure: Endoscopic therapy; Drug: Anticoagulation; Drug: Non-selective beta blockers

Study type: Interventional

Funder types: Other

Identifiers

NCT02485184

PVT-TIPS2

Details and patient eligibility

About

portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis in liver cirrhosis with variceal bleeding.

Full description

Portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis in liver cirrhosis with variceal bleeding. However, the safety of transjugular intrahepatic portosystemic shunt remains uncertain in patients with portal vein thrombosis.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. liver cirrhosis (histological or clinical);
2. Significant variceal bleeding >5 days and ≤ 42 days
3. Successful treatment of the index bleed by means of vasoactive drugs and/or endoscopic treatment
4. Portal vein thrombosis occlusion>=25% of the vessel lumen;
5. Presence of ascites
6. Child-Pugh score 8-12 at inclusion
7. Age 18 to 70 years

Exclusion criteria

1. Bleeding from isolated gastric or ectopic varices
2. Contraindications to non-selective beta blockers (chronic obstructive pulmonary disease, asthma, aortic stenosis, atrioventricular block, intermittent claudication, and psychosis)
3. Contraindications to TIPS : extensive potral vein thrombosis, fibrotic cord replacing original main portal vein; bilirubin>3.5 mg/dL, plasma creatinine>2.1 mg/dL, Child-Pugh score >=13points
4. A history of significant heart failure (New York Heart Association class III and IV)
5. Overt hepatic encephalopathy,
6. Prehepatic portal hypertension
7. Malignancy (including hepatocellular carcinoma) or a concomitant disease with reduced life expectancy
8. Uncontrolled infection and sepsis
9. Previous treatment to prevent rebleeding with a portosystemic shunt,TIPS or with pharmacological therapy with non-selective beta blockers and endoscopic variceal ligation
10. Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

TIPS group

Active Comparator group

Description:

Transjugular intrahepatic portosystemic shunt

Treatment:

Procedure: Transjugular intrahepatic portosystemic shunt

ET & drugs groups

Active Comparator group

Description:

1. Endoscopic therapy. 2. Non-selective beta blockers. 3. Anticoagulation therapy.

Treatment:

Drug: Non-selective beta blockers

Drug: Anticoagulation

Procedure: Endoscopic therapy