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.
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
- Recruiting
Veteran General Hospital-Taipei
Taipei
Ming-Chih Hou
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.
- Conditions
- Gastric Varix, Sepsis, Liver Cirrhoses, Fever
- 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 group | Role | What they receive |
|---|---|---|
| Antibiotic | Experimental | Participate will be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration Receives: Drug: Ertapenem |
| Control | No intervention | Participate 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.
Prevetion of sepsis
If Antibiotic Prophylaxis can reduce sepsis in Patients Undergoing GVO
Measured: 3 years
Secondary outcomes (3)
Rebleeding rate
If Antibiotic Prophylaxis can reduce GV rebleeding rate
Measured: 3 years
Pevention of Refractory bacterial infection
If Antibiotic Prophylaxis can reduce infection rate in Patients Undergoing GVO
Measured: 3 years
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.
- First posted28 Oct 2019
- Study start28 Jan 2017
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric VarixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ming-Chih Hou, Principal investigator, Taipei Veterans General Hospital, Taiwan
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis in Patients Undergoing Endoscopic Injection of Cyanoacrylate for Primary and Secondary Prevention of Gastric Variceal Bleeding
- ClinicalTrials.gov ID
- NCT04140578
- Acronym / sponsor ID
- ABX-GV / 2017-01-027C
- Conditions
- Gastric Varix, Sepsis, Liver Cirrhoses, Fever
- Keywords
- Gastric variceal rebleeding, Sepsis, cyanoacrylate injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 28 Jan 2017 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic | Experimental | Drug: ErtapenemParticipate will be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration |
| Control | No intervention | –Participate will not be acepted ertapenem(1g) iv before endoscopic cyanoacrylate injection obliteration |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with live cirrhosis and/or hepatoma
- Aged 20 to 85, who had endoscopy-treatment EV(-)GV(+)or EV<GV
Key exclusion criteria (3 listed)
- Had a terminal illness of any major organ system,such as heart failure, kindey failure,COPD
- Patients recieve antibiotics recently.
- Patients suspected infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErtapenemAlso: Invanzinject from iv drip before endoscopic cyanoacrylateinjection obliteration | Drug | Antibiotic |
Primary outcome
Prevetion of sepsis
Time frame: 3 years
If Antibiotic Prophylaxis can reduce sepsis in Patients Undergoing GVO
3 secondary outcomes
Rebleeding rate
Time frame: 3 years
Pevention of Refractory bacterial infection
Time frame: 3 years
Mortality
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming-Chih Hou principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
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.