Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding
Information source: Korea University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Variceal Bleeding; Cirrhosis
Intervention: Endoscopic band ligation (Procedure); Propranolol (Drug); endoscopic band ligation and propranolol (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: Korea University Official(s) and/or principal investigator(s): Soon Ho Um, Prof, Principal Investigator, Affiliation: Korea University
Overall contact: Soon Ho Um, Prof, Phone: 82-2-920-5019, Email: umsh@korea.ac.kr
Summary
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.
Clinical Details
Official title: Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: First esophageal variceal bleeding
Secondary outcome: Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Soon Ho Um, Prof, Phone: 82-2-920-5019, Email: umsh@korea.ac.kr
Korea University Anam Hospital, Seoul 136-705, Korea, Republic of; Recruiting
Additional Information
Starting date: September 2006
Last updated: August 25, 2009
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