The Effect of Carvedilol VS Endoscopic Therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding
NCT02695732 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 792
Last updated 2016-03-01
Summary
To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.
Conditions
- Liver Cirrhosis
- Esophageal and Gastric Varices
Interventions
- DRUG
-
Carvedilol
Carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d.Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm.
- DEVICE
-
endoscopy
Patients receiving endoscopic therapy (either endoscopic ligation or cyanoacrylate injection) every 4 weeks until eradication of varices.
Sponsors & Collaborators
-
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
collaborator OTHER -
Shanghai Public Health Clinical Center
collaborator OTHER_GOV -
ShuGuang Hospital
collaborator OTHER -
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
collaborator OTHER -
Gongli Hospital, School of Medicine, The Second Military Medical University
collaborator UNKNOWN -
Eastern Hepatobiliary Surgery Hospital
collaborator OTHER -
Shanghai Zhongshan Hospital
lead OTHER
Principal Investigators
-
Shiyao Chen, Professor · Shanghai Zhongshan Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-31
- Primary Completion
- 2018-09-30
- Completion
- 2018-09-30
Countries
- China
Study Locations
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