Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices

Not Applicable

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

• Registration Number: NCT03045783
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-04
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-04
• Last Update Submitted: 2017-02-04
• Study First Posted: 2017-02-07
• Last Update Posted: 2017-02-07
• Primary Completion: 2019-03
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 912

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylactic use of antibiotics group	Cefotiam	Prophylactic use of antibiotics during 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
Rebleeding rate	2 months	Patients will be followed up and receive an endoscopic examination after patients have been followed up for 2 months.
Mortality rate	2 months	The investigators observe the mortality events during 2 months
All clinical events	2 months	All clinical events were defined as occurrence rebreeding, ascitic fluid infection, portal vein thrombosis, or death.
Serum endotoxin	before and the first day after endoscopic treatment
inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta，IL-2R, IL-10	before and the first day after endoscopic treatment

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China