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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00921349

Enrollment

140

Registered

2009-06-16

Start date

2004-12-31

Completion date

2009-05-31

Last updated

2009-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Variceal Bleeding, Cirrhosis

Keywords

Prophylaxis, ligation, beta blockers, First bleeding rate

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.

Interventions

PROCEDURELigation of varices

all varices are ligated until obliteration

DRUGNadolol

Nadolol (beta-blocker)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
The primary end points of the study were the first episode of variceal bleeding.	2 years

Secondary

Measure	Time frame
The secondary end points were adverse events related to treatment and death of any cause.	2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026