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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921349
• Other study ID #: EVL+Nadolol
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2009
• Last updated: June 15, 2009
• Start date: December 2004
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: National Science Council, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis
• Hemorrhage
• Liver Cirrhosis
• Variceal Bleeding

Intervention

Procedure:
• Ligation of varices
all varices are ligated until obliteration

Drug:
• Nadolol
Nadolol (beta-blocker)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Science Council, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end points of the study were the first episode of variceal bleeding.		2 years	No
Secondary	The secondary end points were adverse events related to treatment and death of any cause.		2 years	Yes