Clinical Trial: The Effect of Carvedilol VS Endoscopic Therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding

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

Official Title: Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding Comparing Carvedilol and Endoscopic Therapy: A Multicenter Randomized Controlled Trial

Brief Summary: To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.

Detailed Summary: The study is a randomized controlled trial. Patients randomly enter into two treatment groups: 1)the Carvedilol group and 2)the endoscopy group. Treatment allocation is by block randomization, with an two-to-one ratio for Carvedilol and endoscopy. The results are concealed in opaque envelopes. The dose of Carvedilol is titrated according to systolic arterial blood pressure (ABPsys) and heart rate (HR). Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm. Carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d. Patients receiving endoscopic therapy every 4 weeks until eradication of varices. Patients will come for clinic visit every 6 months, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.
Sponsor: Shanghai Zhongshan Hospital

Current Primary Outcome: Bleeding rate [ Time Frame: through study completion，an average of 18 months ]

The investigators observe the variceal bleeding events during the study


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality rate [ Time Frame: through study completion，an average of 18 months ]
    The investigators observe the mortality events during the study due to variceal bleeding, hepatic encephalopathy, liver failure, hepatic cellular carcinoma, hepatic-renal syndrome and spontaneous bacterial peritonitis.
  • Adverse events [ Time Frame: through study completion，an average of 18 months ]
    The investigators observe any severe adverse events caused by drug or endoscopic treatment.


Original Secondary Outcome: Same as current

Information By: Shanghai Zhongshan Hospital

Dates:
Date Received: February 25, 2016
Date Started: December 2015
Date Completion: September 2018
Last Updated: February 25, 2016
Last Verified: February 2016