Overview

A Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
Summary
The value of banding ligation plus beta blocker in the prophylaxis of first episodes of variceal bleeding has not yet been evaluated. This study was conducted to compare the efficacy and safety of banding ligation plus nadolol versus nadolol in the prophylaxis of first bleeding in cirrhotic patients with high-risk esophageal varices.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Science Council, Taiwan
Treatments:
Adrenergic beta-Antagonists
Nadolol
Criteria
Inclusion Criteria:

1. the cause of portal hypertension was cirrhosis

2. the degree of esophageal varices was F2 (moderate varices) or more, associated with
any of red color signs (red wale markings, cherry red spots or hematocystic spots)

3. no history of hemorrhage from esophageal varices

4. no current treatment with beta-blockers

5. cirrhosis was based on results of liver biopsy, or clinical and biochemical
examinations and image studies

Exclusion Criteria:

1. age greater than 75 years old or younger than 20 years old

2. association with malignancy, uremia or other serious medical illness which may reduce
the life expectancy

3. presence of refractory ascites, hepatic encephalopathy or marked jaundice (serum
bilirubin > 10 mg/dl)

4. history of shunt operation, transjugular intrahepatic portosystemic stent shunt or
endoscopic therapy (EIS or EVL)

5. had contraindications to beta-blockers, such as asthma, heart failure, complete
atrioventricular block, hypotension ( systolic blood pressure < 90 mmHg), pulse rate <
60/ min

6. unable to cooperate