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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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TIPS Versus Endoscopic Therapy for the Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial

Conditions
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Portal Vein Thrombosis, Liver Cirrhosis

Intervention / Treatment
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* Procedure: Transjugular intrahepatic portosystemic shunt
* Drug: Non-selective beta blockers
* Procedure: Endoscopic therapy
* Drug: Anticoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria liver cirrhosis (histological or clinical); Significant variceal bleeding >5 days and ≤ 42 days Successful treatment of the index bleed by means of vasoactive drugs and/or endoscopic treatment Portal vein thrombosis occlusion>=25% of the vessel lumen; Presence of ascites Child-Pugh score 8-12 at inclusion Age 18 to 70 years Exclusion criteria Bleeding from isolated gastric or ectopic varices Contraindications to non-selective beta blockers (chronic obstructive pulmonary disease, asthma, aortic stenosis, atrioventricular block, intermittent claudication, and psychosis) 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 A history of significant heart failure (New York Heart Association class III and IV) Overt hepatic encephalopathy, Prehepatic portal hypertension Malignancy (including hepatocellular carcinoma) or a concomitant disease with reduced life expectancy Uncontrolled infection and sepsis Previous treatment to prevent rebleeding with a portosystemic shunt,TIPS or with pharmacological therapy with non-selective beta blockers and endoscopic variceal ligation Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TIPS group<br>Transjugular intrahepatic portosystemic shunt | Procedure: Transjugular intrahepatic portosystemic shunt<br>* Transjugular intrahepatic portosystemic shunt refers to an interventional radiological procedure by placing a stent between portal vein and hepatic vein. No specific device was used in the Interventional field.<br>|
| Active Comparator: ET & drugs groups<br>Endoscopic therapy. Non-selective beta blockers. Anticoagulation therapy. | Drug: Non-selective beta blockers<br>* Non-selective beta blockers are the drugs for reducing the portal pressure.<br>* Other names: propranolol;Procedure: Endoscopic therapy<br>* Endoscopic therapy includes the endoscopic variceal band ligation<br>Drug: Anticoagulation<br>* Anticoagulation therapy includes heparin and warfarin.<br>* Other names: warfarin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause rebleeding or all-cause death | Cumulative incidence of all-cause rebleeding or all-cause death | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Portal vein recanalization | Incidence of portal vein recanalization | 3 years | 
| Other decompensations of portal hypertension | defined as ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome | 3 years | 
| adverse events of treatment | Incidence of adverse events of treatment | 3 years | 
| Quality of life | quality of life assessed by the SF-36 health survey | 3 years | 
| Overall survival | Overall survival rate | 3 years | 
| Hepatocellular Carcinoma | Incidence of Hepatocellular Carcinoma | 3 years |