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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Force Military Medical University, China; Fourth Military Medical University
• Collaborators: First Affiliated Hospital of Xinjiang Medical University; Shandong Provincial Hospital; Southern Medical University, China; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital of Nanchang University; Third Affiliated Hospital, Sun Yat-Sen University
• Treatments: Adrenergic beta-Antagonists; Propranolol; Warfarin

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