Cirrhosis, Portal Hypertension, and Esophageal Variceal Bleeding
Conditions
Interventions
Carvedilol group:Endoscopic variceal ligation combined with carvedilol
Propranolol group:Endoscopic variceal ligation combined with propranolol
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (Eligible patients must meet all the following criteria) 1. Age: 18-75 years; 2. Endoscopically confirmed esophageal variceal bleeding; 3. Time interval between index bleeding and randomization greater than 5 days; 4. Cirrhosis: Diagnosed based on clinical presentation, laboratory tests, imaging tests, or liver biopsy.
Exclusion criteria
Exclusion criteria: (Exclusion criteria if any of the following conditions are met) 1. Uncontrolled bleeding before randomisation; 2. History of gastric variceal bleeding; 3. Non-cirrhotic portal hypertension; 4. Hepatocellular carcinoma or other malignancies; 5. CTP score of C; 6. Previous treatment with more than one session of endoscopic variceal ligation or other treatments for esophageal variceal bleeding, including endoscopic injection sclerotherapy (EIS), transjugular intrahepatic portosystemic shunt (TIPS), or surgery; 7. Portal vein thrombosis or portal cavernoma; 8. Currently receiving anticoagulant therapy; 9. Use of NSBB in the past 2 weeks; 10. Chronic renal insufficiency with serum creatinine greater than 2 mg/dL; 11. Grade III/IV hepatic encephalopathy; 12. Refractory ascites; 13. Contraindications to NSBB, including heart block, sinus bradycardia, severe hypotension, heart failure, chronic obstructive pulmonary disease, asthma, uncontrolled diabetes, or severe peripheral arterial disease; 14. Terminal illnesses such as heart failure or renal failure, or other conditions with an expected survival of less than 12 months; 15. Pregnancy or breastfeeding; 16. Unsuitable for endoscopic variceal ligation; 17. Refusal to participate or inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variceal rebleeding or all-cause death; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause death;Liver-related death;Complications of portal hypertension (variceal rebleeding, overt ascites, overt hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorenal syndrome, portal vein thrombosis);Hepatocellular carcinoma ;Changes in liver function: Child-Pugh and Model for End-Stage Liver Disease (MELD) scores ;Changes in liver stiffness ; | — |
Countries
China
Contacts
Public ContactYiling Li
The First Hospital of China Medical University
Outcome results
None listed