TerminatedPhase 4

EVL Plus Drug to Prevent Variceal Rebleeding

Taiwan120 participantsStarted 2001-07

Plain-language 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.

Who can participate

Age range20 Years – 75 Years

SexALL

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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,

What they're measuring

rebleeding rate

Trial details

NCT IDNCT00371943

SponsorNational Science and Technology Council, Taiwan

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

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