The Effect of Carvedilol VS Endoscopic Therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding
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|ClinicalTrials.gov Identifier: NCT02695732|
Recruitment Status : Unknown
Verified February 2016 by Shiyao Chen, Shanghai Zhongshan Hospital.
Recruitment status was: Recruiting
First Posted : March 1, 2016
Last Update Posted : March 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis Esophageal and Gastric Varices||Drug: Carvedilol Device: endoscopy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||792 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding Comparing Carvedilol and Endoscopic Therapy: A Multicenter Randomized Controlled Trial|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
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.
Active Comparator: endoscopy
endoscopy，every 4 weeks until eradication of varices
Patients receiving endoscopic therapy (either endoscopic ligation or cyanoacrylate injection) every 4 weeks until eradication of varices.
- Bleeding rate [ Time Frame: through study completion，an average of 18 months ]The investigators observe the variceal bleeding events during the study
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695732
|Contact: Shiyao Chen, Professoremail@example.com|
|Contact: Chu Liu, doctor 86-15201928343 firstname.lastname@example.org|
|Principal Investigator: Shiyao Chen, professor|
|Study Director:||Shiyao Chen, Professor||Shanghai Zhongshan Hospital|