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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the prophylactic use of antibiotics group | Experimental | Half an hour before endoscopic treatment, cefotiam 2.0g intravenous |
|
| Control | No Intervention | Routine endoscopic examination and treatment. Antibiotics are not used before endoscopic treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefotiam | Drug | Prophylactic use of antibiotics group: Half an hour before endoscopic treatment, cefotiam 2.0g intravenous |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyao Chen, Professor | Contact | 86-13601767310 | chen.shiyao@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shiyao Chen, Professor | Shanghai Zhongshan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 12, 2018 | |
| Reset | Mar 21, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 12, 2018 | Mar 21, 2019 |
| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006975 | Hypertension, Portal |
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| ID | Term |
|---|---|
| D015310 | Cefotiam |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
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|
| 2 months |
| D008107 | Liver Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |