Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices (PUoA-EIoTA)

Fudan University

Status

Unknown

Conditions

Gastric Varices

Cirrhosis

Treatments

Drug: Cefotiam

Study type

Interventional

Funder types

Other

Identifiers

NCT03045783

CSY-LCF2-2016

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

Full description

Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.This study is a randomized controlled trial. The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

Enrollment

912 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 y.o. ≤age≤75 y.o.;
Diagnosis of esophageal gastric varices by gastroscopy;
Cirrhotic gastroesophageal variceal bleeding underwent endoscopic injection of tissue adhesive;

Exclusion criteria

age <18 y.o. or age > 75 y.o.;
Never had the variceal bleeding episode before;
Do not have endoscopic injection of tissue adhesive;
The cefotiam contraindications: such as allergies, pregnancy etc;
combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment);
Known infection before endoscopic treatment (Fever, microbial cultures positive, et al.);
Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics;
Acute variceal bleeding within 5 days;
Refuse to participate