Back to resultsEVL Plus Drug to Prevent Variceal Rebleeding
Primary Purpose
Bleeding
Status
Terminated
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
band ligation
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding focused on measuring variceal bleeding,band ligation, beta-blocker, had history of esophageal variceal bleeding
Eligibility Criteria
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.
Sites / Locations
- Gin-Ho Lo
Outcomes
Primary Outcome Measures
rebleeding rate
Secondary Outcome Measures
complications
Full Information
NCT ID
NCT00371943
First Posted
September 1, 2006
Last Updated
September 14, 2006
Sponsor
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00371943
Brief Title
EVL Plus Drug to Prevent Variceal Rebleeding
Official Title
A Controlled Trial of Ligation Plus Drug Vs. Drug Alone in the Prevention of Variceal Rebleeding
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Terminated
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Science Council, Taiwan
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding
Keywords
variceal bleeding,band ligation, beta-blocker, had history of esophageal variceal bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
band ligation
Primary Outcome Measure Information:
Title
rebleeding rate
Secondary Outcome Measure Information:
Title
complications
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gin Ho Lo
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gin-Ho Lo
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
12. IPD Sharing Statement
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EVL Plus Drug to Prevent Variceal Rebleeding
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