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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Multicenter Randomized Controlled Trial

Conditions
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Gastric Varices, Cirrhosis

Intervention / Treatment
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* Drug: Cefotiam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic use of antibiotics group<br>Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous | Drug: Cefotiam<br>* Prophylactic use of antibiotics group：Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous<br>* Other names: HaiTiShu;|
| No Intervention: On-demand group<br>Routine endoscopic examination and treatment. Antibiotics are not used during endoscopic treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of infection after endoscopic treatment | Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding rate | Patients will be followed up and receive an endoscopic examination after patients have been followed up for 2 months. | 2 months | 
| Mortality rate | The investigators observe the mortality events during 2 months | 2 months | 
| All clinical events | All clinical events were defined as occurrence rebreeding, ascitic fluid infection, portal vein thrombosis, or death. | 2 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric varices, endoscopic injection of tissue adhesive