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| Name | Class |
|---|---|
| Lanzhou University Second Hospital | OTHER |
| Beijing Ditan Hospital | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Renmin Hospital of Wuhan University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic use of antibiotics group | Experimental | Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous |
|
| On-demand group | No Intervention | Routine endoscopic examination and treatment. Antibiotics are not used during endoscopic treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefotiam | Drug | Prophylactic use of antibiotics group:Prophylactic use of antibiotics during 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 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiyao CHEN, M.D. | Zhongshan Hospital, Fudan University, Shanghai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Shanghai | Shanghai Municipality | 200032 | China |
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| 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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| OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
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| 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 |
| 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 |