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

Shanghai Zhongshan Hospital792 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

792

Conditions

Liver Cirrhosis Esophageal and Gastric Varices

Interventions

CarvedilolDRUG

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.

endoscopyDEVICE

Patients receiving endoscopic therapy (either endoscopic ligation or cyanoacrylate injection) every 4 weeks until eradication of varices.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Bleeding rate

The investigators observe the variceal bleeding events during the study

Time frame: through study completion，an average of 18 months

Secondary Outcomes

Mortality rate

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.

Time frame: through study completion，an average of 18 months

Adverse events

The investigators observe any severe adverse events caused by drug or endoscopic treatment.

Time frame: through study completion，an average of 18 months

Central Contacts

Shiyao Chen, Professor

CONTACT

86-13601767310 chen.shiyao@zs-hospital.sh.cn

Data from ClinicalTrials.gov

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