Clinical Trial: Preventing Recurrent Bleeding After Eradication of Esophageal Varices

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Banding Ligation Plus Propranolol Versus Banding Ligation to Prevent Rebleeding of Esophageal Varices

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Kaohsiung Veterans General Hospital.

Current Primary Outcome:

  • recurrent esophageal variceal bleeding [ Time Frame: 6 years ]
    recurrent esophageal variceal bleeding after eradication of esophageal varices
  • mortality or liver transplantation [ Time Frame: 6 years ]
    mortality or liver transplantation after eradication of esophageal varices


Original Primary Outcome: Same as current

Current Secondary Outcome: adverse effects [ Time Frame: 6 years ]

adverse effects associated with non-selective beta-blockers and banding ligation


Original Secondary Outcome: Same as current

Information By: Kaohsiung Veterans General Hospital.

Dates:
Date Received: April 12, 2016
Date Started: June 2013
Date Completion:
Last Updated: April 12, 2016
Last Verified: April 2016