NCT04140578

Brief Summary

We design a randomized trial to clarify the necessity of antibiotic prophylaxis for the patients chronic liver disease with gastric varices treated by elective GVO.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
57mo left

Started Jan 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jan 2017Dec 2030

Study Start

First participant enrolled

January 28, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

13.9 years

First QC Date

August 29, 2019

Last Update Submit

October 24, 2019

Conditions

Gastric VarixSepsisLiver CirrhosesFever

Keywords

Gastric variceal rebleedingSepsiscyanoacrylate injection

Outcome Measures

Primary Outcomes (1)

  • Prevetion of sepsis

    If Antibiotic Prophylaxis can reduce sepsis in Patients Undergoing GVO

    3 years

Secondary Outcomes (3)

  • Rebleeding rate

    3 years

  • Pevention of Refractory bacterial infection

    3 years

  • Mortality

    3 years

Study Arms (2)

Antibiotic

EXPERIMENTAL

Participate will be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration

Drug: Ertapenem

Control

NO INTERVENTION

Participate will not be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration

Interventions

ErtapenemDRUG

inject from iv drip before endoscopic cyanoacrylateinjection obliteration

Also known as: Invanz
Antibiotic

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with live cirrhosis and/or hepatoma
  • Aged 20 to 85, who had endoscopy-treatment EV(-)GV(+)or EV\<GV

You may not qualify if:

  • Had a terminal illness of any major organ system,such as heart failure, kindey failure,COPD
  • Patients recieve antibiotics recently.
  • Patients suspected infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veteran General Hospital-Taipei

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Esophageal and Gastric VaricesSepsisFever

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBody Temperature ChangesSigns and Symptoms

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ming-Chih Hou

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Chih Hou, MD

CONTACT

886-2-28712111mchou@vghtpe.gov.tw

Pei-Chang Lee, MD

CONTACT

886-2-28712111pclee7@vghtpe.gov.tw

Study Design

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

Study Record Dates

First Submitted

August 29, 2019

First Posted

October 28, 2019

Study Start

January 28, 2017

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

October 28, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)