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EVL Plus Drug to Prevent Variceal Rebleeding

Sponsored by National Science and Technology Council, Taiwan

About this trial

Last updated 20 years ago

Study ID

EVL

Status

Terminated

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

20 to 75 Years
All Sexes

Trial Timing

Ended 21 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

1. Acute bleeding from esophageal varices (defined below);

2. the etiology of portal hypertension was cirrhosis; and

3. 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

1. association with hepatocellular carcinoma or other malignancy,

2. association with cerebral vascular accident, uremia, sepsis or other debilitating disease,

3. had history of gastric variceal bleeding,

4. received beta blocker within one month prior to entry,

5. 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).

6. had history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt), EIS or EVL,

7. deep jaundice (serum bilirubin >10mg/dl),

8. encephalopathy greater than stage II,

9. failure in control of index variceal bleeding,

10. death within 24 hours of admission, or

11. refused to participate in the trial.