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Gastric VarixPhase 4ABX-GVNCT04140578

Antibiotic Prophylaxis in Patients Undergoing GVO

A Phase 4 study testing Ertapenem in people with Gastric Varix and Sepsis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Gastric Varix, Sepsis, Liver Cirrhoses
What is being tested?
Ertapenem
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteTaiwan
Study dates
28 Jan 2017to 31 Dec 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site, 1 recruiting
  • Veteran General Hospital-Taipei

    Taipei

    Ming-Chih Hou

    Recruiting

Other trials in Taiwan

About this study

Official title: Antibiotic Prophylaxis in Patients Undergoing Endoscopic Injection of Cyanoacrylate for Primary and Secondary Prevention of Gastric Variceal Bleeding

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.

Read the detailed description

Gastric varices is not uncommon is patients with chronic liver diseases including liver cirrhosis and hepatocellular carcinoma. Occurrence of gastric varices (GV) rupture is less often than esophageal varices (EV) but it is characteristic of higher rebleeding rate and mortality and represents an even tougher problem than EV hemorrhage. Endoscopic treatment is an alternative in the management of GV bleeding. Injection sclerotherapy has been applied to arrest GV hemorrhage but it is associated with a high rebleeding rate (50~90%) and thus is regarded as only a temporary hemostatic measure. The advantage of endoscopic variceal ligation is not suggested due to its high rebleeding rate more than 50%. Endoscopic injection of N-butyl-2-cyanoacrylate, a so-called "tissue glue",is more effective to treat GV bleeding because of more than 90% successful rate to arrest acute bleeding. The theoretical advantages of tissue glue derives from its unique ability to plug the varix lumen immediately after injection into varices. However, its rebleeding rate is still high around 30~40% and has potential treatment-related morbidity such as embolic and septic complications. Regardless of these disadvantage, the guideline form major international society and Bavenoconsensus recommend GVO as the first treatment of choice for GV bleeding. Therefore how to prevent the potential complications and reduce rebleedingremains an important and practical issue.

With regarding to potential septic infections and rebleeding, the effects of impaired leukocyte function in cirrhotic patients and reduced immunity and increased gut permeability of severe hemorrhagic patients were contributory. In these immunocompromised hosts, when invasive procedure such as GVO is deployed for these patients, the septic complication become un-neglectable, We found (Gastrointest Endosc 2001) more than 1/3 patients undergoing GVO may complicated with bacteremia. Although most of these bacteremia were self-limited, 2% died of sepsis. Moreover, lots of cases were reported due to persistent and recurrent bacterial infections caused by GVO. Antibiotic prophylaxis has been suggested as an integral part for the management of cirrhotic patients with acute varicealbleeding by major international society and Baveno consensus. However, there is no evidence to suggest antibiotic prophylaxis for the patients treated by elective GVO. Therefore 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.

Being tested
Ertapenem
Keywords
Gastric variceal rebleeding, Sepsis, cyanoacrylate injection
Medical subject headings
Esophageal and Gastric Varices, Sepsis, Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErtapenemDrug

    Also called Invanz

    inject from iv drip before endoscopic cyanoacrylateinjection obliteration

Study groups in NCT04140578
Study groupRoleWhat they receive
AntibioticExperimentalParticipate will be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration
Receives: Drug: Ertapenem
ControlNo interventionParticipate will not be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevetion of sepsis

    If Antibiotic Prophylaxis can reduce sepsis in Patients Undergoing GVO

    Measured: 3 years

Secondary outcomes (3)
  1. Rebleeding rate

    If Antibiotic Prophylaxis can reduce GV rebleeding rate

    Measured: 3 years

  2. Pevention of Refractory bacterial infection

    If Antibiotic Prophylaxis can reduce infection rate in Patients Undergoing GVO

    Measured: 3 years

  3. Mortality

    If Antibiotic Prophylaxis can decrease mortality in Patients Undergoing GVO

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2019
  2. Study start28 Jan 2017
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04140578
Sponsor's protocol ID
2017-01-027C
Acronym
ABX-GV
Status last verified
Oct 2019
First submitted
29 Aug 2019
Last updated
28 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ertapenem in people with Gastric Varix and Sepsis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ming-Chih Hou, MD (886-2-28712111 ext. 7877, mchou@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevetion of sepsis (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.

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