Status:
UNKNOWN
Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
Lead Sponsor:
Korea University
Conditions:
Variceal Bleeding
Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
Current guidelines recommend prophylactic treatment with propranolol or endoscopic band ligation (EBL) to prevent variceal bleeding in patients with medium or large varices. However, it is unclear whi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00965900
Start Date
September 1 2006
End Date
May 1 2021
Last Update
August 23 2017
Active Locations (1)
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1
Korea University Anam Hospital
Seoul, South Korea, 136-705