Efficiency and Safety of 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 assess the efficiency and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

Detailed Description
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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: the prophylactic use of antibiotics group and 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.

Official Title
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Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A 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: 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.

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: None (Open Label)


Arms and Interventions

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

 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