Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices

Fudan University

Status

Unknown

Conditions

Gastric Varices

Cirrhosis

Treatments

Drug: Cefotiam

Study type

Interventional

Funder types

Other

Identifiers

NCT02693951

CSY-LCF-2016

Details and patient eligibility

About

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

Full description

At present, there is still a controversy about the application of antibiotics in the treatment of patients with non acute hemorrhage of esophageal varices. This study is a randomized controlled trial. Patients randomly enter two treatment groups:

the prophylactic use of antibiotics group

and
the non-prophylactic use of antibiotics group

Treatment allocation is by block randomization with an equal number for both groups. The incidence of infection after endoscopic treatment will be analyzed.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
age between 18-75 years old;
Diagnosis of esophageal gastric varices by gastroscopy
Preparation of endoscopic injection of tissue adhesive

Exclusion criteria

No esophageal gastric varices bleeding history;
Esophageal varices or gastric varices which temporarily won't be treated by endoscopic therapy;
The cefotiam contraindications: such as allergies, pregnancy etc;
Patients with the other malignant tumor except liver cancer;
The preoperative diagnosis of infection;
The large amount of ascites;
The acute bleeding period (< 5 days);
Patients refused to participate in the study.