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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00921349
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : June 16, 2009
Information provided by:
National Science Council, Taiwan

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 Type : Interventional  (Clinical Trial)
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 : December 2004
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Nadolol
U.S. FDA Resources

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)

Primary Outcome Measures :
  1. The primary end points of the study were the first episode of variceal bleeding. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The secondary end points were adverse events related to treatment and death of any cause. [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: National Science Council Identifier: NCT00921349     History of Changes
Other Study ID Numbers: EVL+Nadolol
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: June 16, 2009
Last Verified: June 2009

Keywords provided by National Science Council, Taiwan:
beta blockers
First bleeding rate

Additional relevant MeSH terms:
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents