NCT01970748

Brief Summary

Randomized comparison within the endoscopic esophageal varices ligation versus non-selective beta-blocker in the primary prevention of esophageal variceal bleeding in patients with HCC.

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
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2009

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, 2009

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

14.4 years

First QC Date

October 22, 2013

Last Update Submit

August 29, 2019

Conditions

Bleeding Esophageal VaricesHepatocellular Carcinoma

Keywords

Variceal bleedingPortal hypertensionHepatocellular carcinomaEndoscopic variceal ligationNon-selective beta-blocker

Outcome Measures

Primary Outcomes (1)

  • Bleeding

    2 years

Secondary Outcomes (1)

  • Complication survival

    2 years

Study Arms (2)

Propranolol

PLACEBO COMPARATOR

Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate\>55 or systemic blood pressure\>90mmHg)

Drug: Propranolol

Esophageal variceal ligation

ACTIVE COMPARATOR

Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy. After eradication, follow-up endoscopy every 3 months and variceal ligation again if recurrence.

Procedure: Esophageal variceal ligation

Interventions

PropranololDRUG

Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate\>55 or systemic blood pressure\>90mmHg)

Also known as: Inderal, Cardolol
Propranolol
Esophageal variceal ligationPROCEDURE

Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy

Also known as: EVL
Esophageal variceal ligation

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 20 and 80 years old
  • Hepatocellular carcinoma (HCC) associated with esophageal varices
  • F2 or F3 esophageal varices (Beppu et al classification)
  • Hepatocellular carcinoma (HCC) associated with portal thrombosis

You may not qualify if:

  • History of esophageal variceal bleeding
  • Had received endoscopic variceal ligation (EVL) or endoscopic injection sclerotherapy (EIS)
  • Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...)
  • Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Related Publications (1)

  • Yang TC, Chen WC, Hou MC, Chen PH, Lee PC, Chang CY, Lu HS, Chen YJ, Hsu SJ, Huang HC, Luo JC, Huang YH, Lee FY. Endoscopic variceal ligation versus propranolol for the primary prevention of oesophageal variceal bleeding in patients with hepatocellular carcinoma: an open-label, two-centre, randomised controlled trial. Gut. 2024 Mar 7;73(4):682-690. doi: 10.1136/gutjnl-2023-330419.

    PMID: 38123994DERIVED

MeSH Terms

Conditions

Carcinoma, HepatocellularHypertension, Portal

Interventions

Propranolol

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Ming-Chih Hou, MD

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Chih Hou, MD

CONTACT

886-2-28712121mchou@vghtpe.gov.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 28, 2013

Study Start

August 1, 2009

Primary Completion

December 25, 2023

Study Completion

December 31, 2025

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations

TW(1)