Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.
Cirrhotic patients with acute or recent esophageal variceal bleeding undergo banding ligation at 1-month interval until eradication of esophageal varices. Patients start propranolol (start with 30 mg daily) at 6th day after control of acute bleeding till eradication of esophageal varices, aiming at decreasing pulse rate to 25% or to 55 bpm while systolic pressure is above 85 mmHg. Patients randomized to propranolol group continue propranolol after eradication of esophageal varices. Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. Patients are followed to evaluate the incidence of rebleeding, adverse effects and survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.
Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, Taiwan
RECRUITINGrecurrent esophageal variceal bleeding
recurrent esophageal variceal bleeding after eradication of esophageal varices
Time frame: 6 years
mortality or liver transplantation
mortality or liver transplantation after eradication of esophageal varices
Time frame: 6 years
adverse effects
adverse effects associated with non-selective beta-blockers and banding ligation
Time frame: 6 years
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