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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis

Conditions
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Variceal Bleeding, Cirrhosis

Intervention / Treatment
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* Procedure: Ligation of varices
* Drug: Nadolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ligation+Nadolol<br>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). | Procedure: Ligation of varices<br>* all varices are ligated until obliteration<br>Drug: Nadolol<br>* Nadolol (beta-blocker)<br>|
| Active Comparator: Nadolol only<br> | Drug: Nadolol<br>* Nadolol (beta-blocker)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end points of the study were the first episode of variceal bleeding. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary end points were adverse events related to treatment and death of any cause. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prophylaxis, ligation, beta blockers, First bleeding rate