Cirrhosis, Gastric Varices
Conditions
Keywords
gastric varices, endoscopic injection of tissue adhesive
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.
Interventions
DRUGCefotiam
Prophylactic use of antibiotics group: Half an hour before endoscopic treatment, cefotiam 2.0g intravenous
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rebleeding rate | 2 months | Patients will 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 |
Countries
China
Contacts
Primary ContactShiyao Chen, Professor
Outcome results
None listed