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

NCT ID: NCT02693951

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-09-30

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.

Conditions

Gastric Varices; Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

the prophylactic use of antibiotics group

Half an hour before endoscopic treatment, cefotiam 2.0g intravenous

Group Type: EXPERIMENTAL

Cefotiam

Intervention Type: DRUG

Prophylactic use of antibiotics group: Half an hour before endoscopic treatment, cefotiam 2.0g intravenous

Control

Routine endoscopic examination and treatment. Antibiotics are not used before endoscopic treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cefotiam

Prophylactic use of antibiotics group: Half an hour before endoscopic treatment, cefotiam 2.0g intravenous

Intervention Type: DRUG

Other Intervention Names

HaiTiShu

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shiyao Chen

Director of department of Gastroenterology, Zhongshan Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shiyao Chen, Professor

Role: STUDY_DIRECTOR

Shanghai Zhongshan Hospital

Locations

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shiyao Chen, Professor

Role: CONTACT

chen.shiyao@zs-hospital.sh.cn

86-13601767310

Facility Contacts

Chengfeng Liu, Doctor

Role: primary

09301010167@fudan.edu.cn

86-15201927474

Other Identifiers

CSY-LCF-2016

Identifier Type: -

Identifier Source: org_study_id