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NCT Number: NCT04140578

Antibiotic Prophylaxis in Patients Undergoing GVO

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Veteran General Hospital-Taipei

Taipei, Taiwan

Location status: Recruiting

Location contact

Ming-Chih Hou

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ertapenem

Drug

inject from iv drip before endoscopic cyanoacrylateinjection obliteration

Other names: Invanz

Primary outcomes

  1. Prevetion of sepsis

    Time frame: 3 years

    If Antibiotic Prophylaxis can reduce sepsis in Patients Undergoing GVO

Secondary outcomes

  1. Rebleeding rate

    Time frame: 3 years

    If Antibiotic Prophylaxis can reduce GV rebleeding rate

  2. Pevention of Refractory bacterial infection

    Time frame: 3 years

    If Antibiotic Prophylaxis can reduce infection rate in Patients Undergoing GVO

  3. Mortality

    Time frame: 3 years

    If Antibiotic Prophylaxis can decrease mortality in Patients Undergoing GVO

Study contacts

Contact information is provided by the study sponsor or research team.

Ming-Chih Hou, MD

CONTACT

[email protected]

886-2-28712111 ext. 7877

Pei-Chang Lee, MD

CONTACT

[email protected]

886-2-28712111 ext. 3972

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

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

Acronym: ABX-GV

Important dates

Study start
2017
Primary completion
2030
Study completion
2030
First posted
Oct 28, 2019
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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