Clinical trial NCT00921349: A Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis
Official title: A Randomized, Controlled Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Variceal Bleeding
Cirrhosis
Keywords: Prophylaxis
ligation
beta blockers
First bleeding rate
Lead sponsor: National Science and Technology Council, Taiwan
Sponsor class: OTHER_GOV
First posted: 2009-06-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 banding ligation plus nadolol versus nadolol in the prophylaxis of first bleeding in cirrhotic patients with high-risk esophageal varices.

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 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

Primary outcomes:
measure: The primary end points of the study were the first episode of variceal bleeding.
timeFrame: 2 years
Secondary outcomes:
measure: The secondary end points were adverse events related to treatment and death of any cause.
timeFrame: 2 years
Other outcomes:
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Study officials:
References: