Status:
COMPLETED
A Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis
Lead Sponsor:
National Science and Technology Council, Taiwan
Conditions:
Variceal Bleeding
Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 ban...
Detailed Description
Currently, endoscopic variceal ligation (EVL) has replaced EIS as the endoscopic treatment of choice for management of bleeding esophageal varices. The advantages of EVL include requiring fewer treatm...
Eligibility Criteria
Inclusion
- the cause of portal hypertension was cirrhosis
- 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)
- no history of hemorrhage from esophageal varices
- no current treatment with beta-blockers
- cirrhosis was based on results of liver biopsy, or clinical and biochemical examinations and image studies
Exclusion
- age greater than 75 years old or younger than 20 years old
- association with malignancy, uremia or other serious medical illness which may reduce the life expectancy
- presence of refractory ascites, hepatic encephalopathy or marked jaundice (serum bilirubin \> 10 mg/dl)
- history of shunt operation, transjugular intrahepatic portosystemic stent shunt or endoscopic therapy (EIS or EVL)
- had contraindications to beta-blockers, such as asthma, heart failure, complete atrioventricular block, hypotension ( systolic blood pressure \< 90 mmHg), pulse rate \< 60/ min
- unable to cooperate
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00921349
Start Date
December 1 2004
End Date
May 1 2009
Last Update
June 16 2009
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