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

Cirrhosis Clinical Trial

Official title:

Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02693951
• Other study ID #: CSY-LCF-2016
• Status: Recruiting
• Phase: N/A
• First received: February 18, 2016
• Last updated: January 4, 2017
• Start date: February 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2017
• Source: Shanghai Zhongshan Hospital
• Contact: Shiyao Chen, Professor
• Phone: 86-13601767310
• Email: chen.shiyao[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis
• Esophageal and Gastric Varices
• Gastric Varices
• Varicose Veins

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of infection after endoscopic treatment	Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment.	1 week	No
Secondary	Rebleeding rate	Patients will receive an endoscopic examination after patients have been followed up for 2 months.	2 months	No
Secondary	Mortality rate	The investigators observe the mortality events during 2 months	2 months	No