EBL Versus EBL and Propranolol for the Prevention of Variceal Rebleeding in Pts With Previous Variceal Treatment

Cirrhosis Clinical Trial

Official title:

RCT Comparing the Efficacies of Endoscopic Band Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding in Patients With Previous Endoscopic Variceal Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00966082
• Other study ID #: EBLPPL-2
• Status: Recruiting
• Phase: Phase 4
• First received: August 25, 2009
• Last updated: August 21, 2017
• Start date: August 2008
• Est. completion date: July 2021

Study information

• Verified date: August 2017
• Source: Korea University
• Contact: Soon Ho Um, Prof
• Phone: 82-2-920-5019
• Email: umsh[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.

Description:

Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal rebleeding. Recently several studies compared the efficacy of EBL alone and with a combination of propranolol and EBL. However, the results of recent studies showed discrepancy. In addition, most of all recent studies included patients without previous endoscopic treatment for varices. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Liver cirrhosis

• Age between 18 and 70 years

• Successful control of esophageal variceal bleeding within 6 weeks before enrollment

Exclusion Criteria:

• Gastric variceal bleeding

• Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min

• Portal vein thrombosis

• Prominent hepatic encephalopathy

• Coexisting untreated malignancy

• Severe cerebrovascular or cardiovascular disease, renal failure

• No previous history of endoscopic, radiologic, or surgical treatment for varices or ascites

• Contraindication to beta-blocker

• Pregnancy

• Refusal to give consent to participate in the trial

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Variceal Bleeding

Intervention

Procedure:
• endoscopic band ligation
Perform EBL until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval
• endoscopic band ligation+Propranolol
Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR =55/min

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rebleeding from esophageal varices	Rebleeding from esophageal varices	2 years
Secondary	Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events	Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events	2 years