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

NCT ID: NCT00921349

Last Updated: 2009-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2009-05-31

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.

Conditions

Variceal Bleeding; Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ligation+Nadolol

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).

Group Type: EXPERIMENTAL

Ligation of varices

Intervention Type: PROCEDURE

all varices are ligated until obliteration

Nadolol

Intervention Type: DRUG

Nadolol (beta-blocker)

Nadolol only

Group Type: ACTIVE_COMPARATOR

Nadolol

Intervention Type: DRUG

Nadolol (beta-blocker)

Interventions

Ligation of varices

all varices are ligated until obliteration

Intervention Type: PROCEDURE

Nadolol

Nadolol (beta-blocker)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: lead

Other Identifiers

EVL+Nadolol

Identifier Type: -

Identifier Source: org_study_id