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

This study has been completed.
Sponsor:
Information provided by:
National Science Council, Taiwan
ClinicalTrials.gov Identifier:
NCT00921349
First received: June 3, 2009
Last updated: June 15, 2009
Last verified: June 2009
History of Changes
  Purpose

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 Intervention Phase
Variceal Bleeding
Cirrhosis
 Procedure: Ligation of varices
Drug: Nadolol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by National Science Council, Taiwan:

Primary Outcome Measures:
  • The primary end points of the study were the first episode of variceal bleeding. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary end points were adverse events related to treatment and death of any cause. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: December 2004
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: National Science Council
ClinicalTrials.gov Identifier: NCT00921349     History of Changes
Other Study ID Numbers: EVL+Nadolol
Study First Received: June 3, 2009
Last Updated: June 15, 2009
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Hemorrhage
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Adrenergic beta-Antagonists
Nadolol
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013