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

National Science Council, Taiwan

Status and phase: Completed; Phase 4

Conditions: Cirrhosis; Variceal Bleeding

Treatments: Procedure: Ligation of varices; Drug: Nadolol

Study type: Interventional

Funder types: Other

Identifiers

NCT00921349

EVL+Nadolol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Ligation+Nadolol

Experimental group

Description:

Multi-ligators were applied. Patients received regular ligation treatment at an interval of 3-4 weeks until variceal obliteration. Intervention; ligation of varices plus beta blockers (Nadolol).

Treatment:

Drug: Nadolol

Procedure: Ligation of varices

Nadolol only

Active Comparator group

Treatment:

Drug: Nadolol