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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00966121

Enrollment

180

Registered

2009-08-26

Start date

2008-08-31

Completion date

2021-07-31

Last updated

2017-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Variceal Bleeding

Keywords

Cirrhosis, Esophagus Disorders, Varicose Veins

Brief 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.

Interventions

PROCEDUREendoscopic 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).

PROCEDUREEBL+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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Rebleeding from esophageal varices	2 years	Rebleeding from esophageal varices

Secondary

Measure	Time frame	Description
Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events	2 years	Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events

Countries

South Korea

Contacts

Primary ContactSoon Ho Um, Prof

umsh@korea.ac.kr82-2-920-5019

Backup ContactYeon Seok Seo, MD

drseo@korea.ac.kr82-2-920-6608

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026