Status:
TERMINATED
EVL Plus Drug to Prevent Variceal Rebleeding
Lead Sponsor:
National Science and Technology Council, Taiwan
Conditions:
Bleeding
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
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 an...
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00371943
Start Date
July 1 2001
End Date
March 1 2005
Last Update
September 15 2006
Active Locations (1)
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1
Gin-Ho Lo
Kaohsiung City, Taiwan, 813