Cirrhosis, Variceal Bleeding
Conditions
Keywords
Cirrhosis, Esophagus Disorders, Varicose Veins
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 which treatment is more useful in regard to prevention of variceal bleeding as well as safety. In addition, the efficacy and safety of the combination of EBL and propranolol is not still defined. 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.
Interventions
PROCEDUREEndoscopic band ligation
* Perform EBL within 7 days after randomization * Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (at 4,8,12 weeks after initial treatment) * Acid suppression using proton pump inhibitor until eradicated. * After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months).
DRUGPropranolol
* start with 20 mg of propranolol b.i.d * Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 55/min * After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
PROCEDUREEBL+Propranolol
1. EBL * Perform EBL within 7 days after randomization * Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (at 4,8,12 weeks after initial treatment) * Acid suppression using proton pump inhibitor until eradicated. * After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months). 2. Propranolol * start with 20 mg b.i.d * Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 55/min * After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
Sponsors
Korea University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First esophageal variceal bleeding | 3 years after enrollment | First esophageal variceal bleeding after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events | 3 years after enrollment | Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events |
Countries
South Korea
Contacts
Primary ContactSoon Ho Um, Prof
Backup ContactYeon Seok Seo, MD
Outcome results
None listed