- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00371943
EVL Plus Drug to Prevent Variceal Rebleeding
September 14, 2006 updated by: National Science Council, Taiwan
A Controlled Trial of Ligation Plus Drug Vs. Drug Alone in the Prevention of Variceal Rebleeding
Both medications with beta-blockers and isosorbide-5-mononitrate and endoscopic variceal ligation have been proven plausible in the prevention of variceal rebleeding.
However, the relative efficacy and safety of the combined treatment for preventing rebleeding remains unresolved.
Study Overview
Detailed Description
Bleeding from esophageal varices is a severe complication of portal hypertension.
After initial control of acute variceal bleeding, patients still carry a high risk of rebleeding.
Of those do rebleed, there is a 20%-35% mortality (1).
Therefore, preventive procedures are required in patients surviving an episode of acute variceal bleeding.
In recent years, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the management of bleeding esophageal varices (2-3).
On the other hand, nonselective beta blockers have been well documented to be effective in reducing variceal rebleeding (4-5).
The addition of isosorbide-5-mononitrate (ISMN) has been shown to be even more effective than propranolol alone in the reduction of portal pressure and in the prevention of variceal rebleeding (6).
Some studies showed that the combination of nadolol and ISMN is more effective than EIS or EVL in the reduction of variceal rebleeding (7-8).
It is still unknown whether EVL combined with nadolol and ISMN is superior to nadolol and ISMN in the prevention of variceal rebleeding.
This study was undertaken to compare the effectiveness and complications of ligation plus nadolol and isosorbide mononitrate vs. nadolol plus isosorbide mononitrate for the prevention of variceal rebleeding.
Study Type
Interventional
Enrollment
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 813
- Gin-Ho Lo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Acute bleeding from esophageal varices (defined below);
- the etiology of portal hypertension was cirrhosis; and
- age was between 20 and 75 years old. The diagnosis of cirrhosis was based on pathology, clinical, biochemical, and sonographic or computed tomographic findings. Acute esophageal variceal bleeding was defined as when blood was directly seen by endoscopy to issue from an esophageal varix, or when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified.
Exclusion Criteria:
- association with hepatocellular carcinoma or other malignancy,
- association with cerebral vascular accident, uremia, sepsis or other debilitating disease,
- had history of gastric variceal bleeding,
- received beta blocker within one month prior to entry,
- had history of contraindication to the use of beta blockers, such as asthma, heart failure, atrioventricular block, bradycardia (pulse rate <55/min) or arterial hypotension (systolic blood pressure<90 mmHg).
- had history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt), EIS or EVL,
- deep jaundice (serum bilirubin >10mg/dl),
- encephalopathy greater than stage II,
- failure in control of index variceal bleeding,
- death within 24 hours of admission, or
- refused to participate in the trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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rebleeding rate
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Secondary Outcome Measures
Outcome Measure |
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complications
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gin Ho Lo, Kaohsiung Veterans General Hospital.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2001
Study Completion
March 1, 2005
Study Registration Dates
First Submitted
September 1, 2006
First Submitted That Met QC Criteria
September 1, 2006
First Posted (Estimate)
September 4, 2006
Study Record Updates
Last Update Posted (Estimate)
September 15, 2006
Last Update Submitted That Met QC Criteria
September 14, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EVL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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