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UNKNOWNPhase 4NCT00965900

Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

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.

Lead sponsor: Korea University•1 locations•View source on ClinicalTrials.gov

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Contacts

Soon Ho Um, Prof

CONTACT

82-2-920-5019 [email protected]

Yeon Seok Seo, MD

CONTACT

82-2-920-6608 [email protected]

Sponsors

Lead Sponsor

Korea University

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.

Age

18 - 70 years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 23, 2017Terms

Trial snapshot

StatusUNKNOWN

PhasePHASE4

Enrollment288

Start dateSep 2006

Last updatedAug 23, 2017

Condition

Variceal Bleeding Cirrhosis

Locations shown

Korea University Anam Hospital

Seoul

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2017Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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