A Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis
Information source: National Science Council, Taiwan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Variceal Bleeding; Cirrhosis
Intervention: Ligation of varices (Procedure); Nadolol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Science Council, Taiwan
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.
Clinical Details
Official title: A Randomized, Controlled Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: The primary end points of the study were the first episode of variceal bleeding.
Secondary outcome: The secondary end points were adverse events related to treatment and death of any cause.
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 treatment sessions to achieve variceal obliteration, lower rebleeding rates
and fewer complications (5-9). Controlled studies that compared EVL with beta-blocker in the
prevention of first variceal bleeding suggested that EVL was at least equal to
beta-blockers in the prophylaxis of first variceal bleeding. However, portal pressure may
be elevated after repeated EVL. Hence the combination of nadolol and EVL is a reasonable
approach to prevent the first episode of variceal bleeding.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: December 2004
Last updated: June 15, 2009
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