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

Phase 4

• Conditions: Esophageal and Gastric Varices; Liver Cirrhosis
• Interventions: Device: endoscopy; Drug: Carvedilol

• Registration Number: NCT02695732
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2015-12
• Status Verified: 2016-02
• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-02-25
• Last Update Submitted: 2016-02-25
• Study First Posted: 2016-03-01
• Last Update Posted: 2016-03-01
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 792

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopy	endoscopy	endoscopy，every 4 weeks until eradication of varices
Carvedilol	Carvedilol	Carvedilol，6.25mg-12.5mg/d,oral,6-36 months

Primary Outcome Measures

Name	Time	Method
Bleeding rate	through study completion，an average of 18 months	The investigators observe the variceal bleeding events during the study

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, China