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

NCT00965900 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2017-08-23

No results posted yet for this study

Summary

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.

Conditions

  • Variceal Bleeding
  • Cirrhosis

Interventions

PROCEDURE

Endoscopic band ligation

* Perform EBL within 7 days after randomization * Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (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).

DRUG

Propranolol

* start with 20 mg of propranolol b.i.d * Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 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)

PROCEDURE

EBL+Propranolol

1. EBL * Perform EBL within 7 days after randomization * Apply 1-2 band/column/session to varices in the distal 5-7 cm of the esophagus till they are eradicated (disappearance or too small to apply band) with interval of 4 weeks (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). 2. Propranolol * start with 20 mg b.i.d * Adjust by 20-40 mg/day reaching reduction by 25 percent in HR or HR less than 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)

Sponsors & Collaborators

  • Korea University

    lead OTHER

Principal Investigators

  • Soon Ho Um, Prof · Korea University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2019-05-31
Completion
2021-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00965900 on ClinicalTrials.gov