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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00966121
Other study ID # EBLPPL-1
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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