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Antibiotic Prophylaxis in Patients Undergoing GVO

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04140578
Acronym
ABX-GV
Enrollment
150
Registered
2019-10-28
Start date
2017-01-28
Completion date
2030-12-31
Last updated
2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Gastric Varix, Liver Cirrhoses, Sepsis

Keywords

Gastric variceal rebleeding, Sepsis, cyanoacrylate injection

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.

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.

Interventions

DRUGErtapenem

inject from iv drip before endoscopic cyanoacrylateinjection obliteration

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. Patients with live cirrhosis and/or hepatoma 2. Aged 20 to 85, who had endoscopy-treatment EV(-)GV(+)or EV\<GV

Exclusion criteria

1. Had a terminal illness of any major organ system,such as heart failure, kindey failure,COPD 2. Patients recieve antibiotics recently. 3. Patients suspected infection.

Design outcomes

Primary

MeasureTime frameDescription
Prevetion of sepsis3 yearsIf Antibiotic Prophylaxis can reduce sepsis in Patients Undergoing GVO

Secondary

MeasureTime frameDescription
Rebleeding rate3 yearsIf Antibiotic Prophylaxis can reduce GV rebleeding rate
Pevention of Refractory bacterial infection3 yearsIf Antibiotic Prophylaxis can reduce infection rate in Patients Undergoing GVO
Mortality3 yearsIf Antibiotic Prophylaxis can decrease mortality in Patients Undergoing GVO

Countries

Taiwan

Contacts

Primary ContactMing-Chih Hou, MD
mchou@vghtpe.gov.tw886-2-28712111
Backup ContactPei-Chang Lee, MD
pclee7@vghtpe.gov.tw886-2-28712111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026