Cirrhosis Clinical Trial
Official title:
Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis
This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.
Status | Recruiting |
Enrollment | 288 |
Est. completion date | May 2021 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Liver cirrhosis - Age between 18 and 70 years - Esophageal varices with high bleeding risk: more than F2 and red color sign - No previous history of upper gastrointestinal bleeding - No previous history of endoscopic, radiologic, or surgical therapy for varices or ascites - Do not take beta-blocker, ACE inhibitor, or nitrate - Child-Pugh score <12 Exclusion Criteria: - Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min - Portal vein thrombosis - Uncontrolled ascites or hepatic encephalopathy - Severe coagulation disorder: prothrombin time <40% (or INR >1.7) or platelet count <30,000/mm3 - Medium or large sized gastric or duodenal varices - Coexisting malignancy - Severe cardiovascular disorder, renal failure, peritonitis, sepsis - Severe erosive esophagitis, severe esophageal stricture, active gastric or duodenal ulcer - Contraindication to beta-blocker - Pregnancy - Refusal to give consent to participate in the trial |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Anam Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | First esophageal variceal bleeding | First esophageal variceal bleeding after enrollment | 3 years after enrollment | |
Secondary | Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events | Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events | 3 years after enrollment |
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