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

Not Applicable

• Conditions: Cirrhosis; Gastric Varices
• Interventions: Drug: Cefotiam

• Registration Number: NCT02693951
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed 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:

1. the prophylactic use of antibiotics group

and

2. 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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-02-29
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-06
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the prophylactic use of antibiotics group	Cefotiam	Half an hour before endoscopic treatment, cefotiam 2.0g intravenous

Primary Outcome Measures

Name	Time	Method
The incidence of infection after endoscopic treatment	1 week	Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment.

Secondary Outcome Measures

Name	Time	Method
Mortality rate	2 months	The investigators observe the mortality events during 2 months
Rebleeding rate	2 months	Patients will receive an endoscopic examination after patients have been followed up for 2 months.

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China