Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis
1 other identifier
interventional
288
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2006
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 25, 2009
CompletedFirst Posted
Study publicly available on registry
August 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedAugust 23, 2017
August 1, 2017
12.7 years
August 25, 2009
August 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
First esophageal variceal bleeding
First esophageal variceal bleeding after enrollment
3 years after enrollment
Secondary Outcomes (1)
Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events
3 years after enrollment
Study Arms (3)
Endoscopic band ligation
ACTIVE COMPARATOREndoscopic band ligation until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment
Propranolol
ACTIVE COMPARATORstart with 20 mg b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
EBL+Propranolol
ACTIVE COMPARATOR* EBL until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment * start with 20 mg of propranolol b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
Interventions
* 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).
* 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)
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korea Universitylead
Study Sites (1)
Korea University Anam Hospital
Seoul, 136-705, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soon Ho Um, Prof
Korea University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 25, 2009
First Posted
August 26, 2009
Study Start
September 1, 2006
Primary Completion
May 1, 2019
Study Completion
May 1, 2021
Last Updated
August 23, 2017
Record last verified: 2017-08