Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00966121
• Other study ID #: EBLPPL-1
• Status: Recruiting
• Phase: Phase 4
• First received: August 25, 2009
• Last updated: August 22, 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

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. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients without previous history of 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

• 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 within 7 days after randomization Apply 1-2 band/column/session to varices in the distal 5-7cm of the esophagus till they are eradicated (Disappearance or too small to apply band) with interval of 4weeks (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).
• EBL+Propranolol
Start with 20 mg b.i.d Adjust by 20-40 mg/d reaching reduction by 25% in HR or HR =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)

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