Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices
NCT ID: NCT03045783
Last Updated: 2017-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
912 participants
INTERVENTIONAL
2016-12-31
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Prophylactic use of antibiotics group
Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous
Cefotiam
Prophylactic use of antibiotics group：Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous
On-demand group
Routine endoscopic examination and treatment. Antibiotics are not used during endoscopic treatment
No interventions assigned to this group
Interventions
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Cefotiam
Prophylactic use of antibiotics group：Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of esophageal gastric varices by gastroscopy;
* Cirrhotic gastroesophageal variceal bleeding underwent endoscopic injection of tissue adhesive;
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Lanzhou University Second Hospital
OTHER
Beijing Ditan Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
Renmin Hospital of Wuhan University
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Shiyao Chen
Professor
Principal Investigators
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Shiyao CHEN, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hospital, Fudan University, Shanghai
Locations
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180 Fenglin Road
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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CSY-LCF2-2016
Identifier Type: -
Identifier Source: org_study_id
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