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

NCT00921349 | Completed Phase 4 DMC

• 1 other identifier: EVL+Nadolol
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Variceal Bleeding; Cirrhosis

Keywords

Prophylaxis; ligation; beta blockers; First bleeding rate

Outcome Measures

Primary Outcomes (1)

• The primary end points of the study were the first episode of variceal bleeding.

  2 years

Secondary Outcomes (1)

• The secondary end points were adverse events related to treatment and death of any cause.

  2 years

Study Arms (2)

Ligation+Nadolol

EXPERIMENTAL

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; Drug: Nadolol

Nadolol only

ACTIVE COMPARATOR

Drug: Nadolol

Interventions

Ligation of varices PROCEDURE

all varices are ligated until obliteration

Ligation+Nadolol

Nadolol DRUG

Nadolol (beta-blocker)

Ligation+Nadolol; Nadolol only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Science and Technology Council, Taiwan: lead

MeSH Terms

Conditions

Fibrosis

Interventions

Nadolol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 16, 2009
• Study Start: December 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 16, 2009

Record last verified: 2009-06