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

Information source: Korea University
ClinicalTrials.gov processed this data on November 27, 2014
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

Page last updated: November 27, 2014

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