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Completed

NCT Number: NCT00921349

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ligation of varices

Procedure

all varices are ligated until obliteration

Nadolol

Drug

Nadolol (beta-blocker)

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

National Science and Technology Council, Taiwan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jun 16, 2009
Registry last updated
Jun 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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