NCT00966121

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

10.9 years

First QC Date

August 25, 2009

Last Update Submit

August 22, 2017

Conditions

CirrhosisVariceal Bleeding

Keywords

CirrhosisEsophagus DisordersVaricose Veins

Outcome Measures

Primary Outcomes (1)

  • Rebleeding from esophageal varices

    Rebleeding from esophageal varices

    2 years

Secondary Outcomes (1)

  • Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events

    2 years

Study Arms (2)

Endoscopic band ligation

ACTIVE COMPARATOR

Perform endoscopic band ligation (EBL) until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval

Procedure: endoscopic band ligation

EBL+Propranolol

ACTIVE COMPARATOR

Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min

Procedure: EBL+Propranolol

Interventions

endoscopic band ligationPROCEDURE

* 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).

Endoscopic band ligation
EBL+PropranololPROCEDURE

* 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)

EBL+Propranolol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • liver cirrhosis
  • age between 18 and 70 years
  • Successful control of esophageal variceal bleeding within 6 weeks before enrollment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, 136-705, South Korea

RECRUITING

MeSH Terms

Conditions

FibrosisEsophageal DiseasesVaricose Veins

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Soon Ho Um, Prof

CONTACT

82-2-920-5019umsh@korea.ac.kr

Yeon Seok Seo, MD

CONTACT

82-2-920-6608drseo@korea.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

August 1, 2008

Primary Completion

July 1, 2019

Study Completion

July 1, 2021

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

KR(1)