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

Primary Purpose

Variceal Bleeding, Cirrhosis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ligation of varices
Nadolol
Sponsored by
National Science Council, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Variceal Bleeding focused on measuring Prophylaxis, ligation, beta blockers, First bleeding rate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ligation+Nadolol

    Nadolol only

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 3, 2009
    Last Updated
    June 15, 2009
    Sponsor
    National Science Council, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00921349
    Brief Title
    A Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis
    Official Title
    A Randomized, Controlled Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    May 2009 (Actual)
    Study Completion Date
    May 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Science Council, Taiwan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Variceal Bleeding, Cirrhosis
    Keywords
    Prophylaxis, ligation, beta blockers, First bleeding rate

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ligation+Nadolol
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Nadolol only
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Ligation of varices
    Intervention Description
    all varices are ligated until obliteration
    Intervention Type
    Drug
    Intervention Name(s)
    Nadolol
    Intervention Description
    Nadolol (beta-blocker)
    Primary Outcome Measure Information:
    Title
    The primary end points of the study were the first episode of variceal bleeding.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    The secondary end points were adverse events related to treatment and death of any cause.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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