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

Sponsor

National Science Council, Taiwan (Other)

Overall Status

Completed

CT.gov ID

NCT00921349

Collaborator

(none)

140

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Variceal Bleeding Cirrhosis	Procedure: Ligation of varices Drug: Nadolol	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Procedure: Ligation of varices all varices are ligated until obliteration Drug: Nadolol Nadolol (beta-blocker)
Active Comparator: Nadolol only	Drug: Nadolol Nadolol (beta-blocker)

Arm

Intervention/Treatment

Experimental: 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).

Procedure: Ligation of varices

all varices are ligated until obliteration

Drug: Nadolol

Nadolol (beta-blocker)

Active Comparator: Nadolol only

Drug: Nadolol

Nadolol (beta-blocker)

Outcome Measures

Primary Outcome Measures

The primary end points of the study were the first episode of variceal bleeding. [2 years]

Secondary Outcome Measures

The secondary end points were adverse events related to treatment and death of any cause. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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