Esophageal and Gastric Varices, Liver Cirrhosis
Conditions
Keywords
Esophageal and Gastric Varices, Primary Prophylaxis, Carvedilol, Endoscopy
Brief summary
To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.
Detailed description
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.
Interventions
DRUGCarvedilol
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.
DEVICEendoscopy
Patients receiving endoscopic therapy (either endoscopic ligation or cyanoacrylate injection) every 4 weeks until eradication of varices.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Public Health Clinical Center
ShuGuang Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Gongli Hospital, School of Medicine, The Second Military Medical University
Eastern Hepatobiliary Surgery Hospital
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* the presence of severe esophageal and gastric varices at upper gastrointestinal endoscopy without a previous haemorrhage * a diagnosis of liver cirrhosis based on histology, clinical or imaging manifestation
Exclusion criteria
* age greater than 80 years old or younger than 18 years old * non-cirrhotic portal hypertension * contraindications to NSBB including bronchospasm, severe bradycardia, severe heart failure, acute pulmonary edema, atrioventricular block and so on * ABPsys less than 95 mmHg or HR less than 50 bpm * prior treatment for prevention of bleeding from EGV * presence of spontaneous bacterial peritonitis or other severe infections * presence of hepatorenal syndrome * uncontrolled hepatic encephalopathy * presence of refractory ascites * pregnancy * presence of portosystemic shunt or portal cavernous transformation * refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding rate | through study completion，an average of 18 months | The investigators observe the variceal bleeding events during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | 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 | through study completion，an average of 18 months | The investigators observe any severe adverse events caused by drug or endoscopic treatment. |
Countries
China
Contacts
Primary ContactShiyao Chen, Professor
Outcome results
None listed