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

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Liver Cirrhosis; Esophageal and Gastric Varices

Treatments: Device: endoscopy; Drug: Carvedilol

Study type: Interventional

Funder types: Other

Identifiers

NCT02695732

CSY-LC02-2016

Details and patient eligibility

About

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

Full 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.

Enrollment: 792 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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792 participants in 2 patient groups

Carvedilol

Experimental group

Description:

Carvedilol，6.25mg-12.5mg/d,oral,6-36 months

Treatment:

Drug: Carvedilol

endoscopy

Active Comparator group

Description:

endoscopy，every 4 weeks until eradication of varices

Treatment:

Device: endoscopy