Back to resultsEndoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
Primary Purpose
Variceal Bleeding, Cirrhosis
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endoscopic band ligation
Propranolol
EBL+Propranolol
Sponsored by
About this trial
This is an interventional prevention trial for Variceal Bleeding focused on measuring Cirrhosis, Esophagus Disorders, Varicose Veins
Eligibility Criteria
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
Sites / Locations
- Korea University Anam HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Endoscopic band ligation
Propranolol
EBL+Propranolol
Arm Description
Endoscopic 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
start 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 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)
Outcomes
Primary Outcome Measures
First esophageal variceal bleeding
First esophageal variceal bleeding after enrollment
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00965900
Brief Title
Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
Official Title
Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Variceal Bleeding, Cirrhosis
Keywords
Cirrhosis, Esophagus Disorders, Varicose Veins
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic band ligation
Arm Type
Active Comparator
Arm Description
Endoscopic 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
Arm Title
Propranolol
Arm Type
Active Comparator
Arm Description
start 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)
Arm Title
EBL+Propranolol
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Endoscopic band ligation
Other Intervention Name(s)
EBL
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
Beta blocker
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
EBL+Propranolol
Other Intervention Name(s)
EBL+Beta blocker
Intervention Description
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).
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)
Primary Outcome Measure Information:
Title
First esophageal variceal bleeding
Description
First esophageal variceal bleeding after enrollment
Time Frame
3 years after enrollment
Secondary Outcome Measure Information:
Title
Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events
Description
Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events
Time Frame
3 years after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soon Ho Um, Prof
Phone
82-2-920-5019
Email
umsh@korea.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Yeon Seok Seo, MD
Phone
82-2-920-6608
Email
drseo@korea.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soon Ho Um, Prof
Organizational Affiliation
Korea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
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