Overview

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

Status:
Unknown status
Trial end date:
2018-09-01
Target enrollment:
0
Participant gender:
All
Summary
To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborators:
Eastern Hepatobiliary Surgery Hospital
Gongli Hospital, School of Medicine, The Second Military Medical University
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
Treatments:
Carvedilol
Criteria
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