Image

Antibiotic Prophylaxis in Patients Undergoing GVO

Antibiotic Prophylaxis in Patients Undergoing GVO

Recruiting
20-85 years
All
Phase 4

Powered by AI

Overview

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.

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.

Eligibility

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.

Study details
    Gastric Varix
    Sepsis
    Liver Cirrhoses
    Fever

NCT04140578

Taipei Veterans General Hospital, Taiwan

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.