Portal Vein Thrombosis, Liver Cirrhosis
Conditions
Brief summary
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
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.
Interventions
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.
Non-selective beta blockers are the drugs for reducing the portal pressure.
PROCEDUREEndoscopic therapy
Endoscopic therapy includes the endoscopic variceal band ligation
DRUGAnticoagulation
Anticoagulation therapy includes heparin and warfarin.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Shandong Provincial Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Southern Medical University, China
First Affiliated Hospital of Xinjiang Medical University
The First Affiliated Hospital of Nanchang University
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause rebleeding or all-cause death | 3 years | Cumulative incidence of all-cause rebleeding or all-cause death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other decompensations of portal hypertension | 3 years | defined as ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome |
| adverse events of treatment | 3 years | Incidence of adverse events of treatment |
| Portal vein recanalization | 3 years | Incidence of portal vein recanalization |
| Overall survival | 3 years | Overall survival rate |
| Hepatocellular Carcinoma | 3 years | Incidence of Hepatocellular Carcinoma |
| Quality of life | 3 years | quality of life assessed by the SF-36 health survey |
Countries
China
Contacts
Primary ContactGuohong Han, MD
Backup ContactYong Lv, MD
Outcome results
None listed