An interventional study of Cefotiam in Gastric Varices and Cirrhosis, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-02-07.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Prevention
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.
169 studies on the registry are indexed under Esophageal and Gastric Varices; 41 are open to participants now.
This study's planned enrollment of 912 is above the median of 104 across 109 interventional studies indexed under Esophageal and Gastric Varices.
Browse Esophageal and Gastric Varices studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
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Exclusion Criteria:
Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous
Drug: Cefotiam
Routine endoscopic examination and treatment. Antibiotics are not used during endoscopic treatment
Prophylactic use of antibiotics group：Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous
Also known as: HaiTiShu
The incidence of infection after endoscopic treatment
Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment
Time frame: 1 week
Rebleeding rate
Patients will be followed up and receive an endoscopic examination after patients have been followed up for 2 months.
Time frame: 2 months
Mortality rate
The investigators observe the mortality events during 2 months
Time frame: 2 months
All clinical events
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, portal vein thrombosis, or death.
Time frame: 2 months
Serum endotoxin
Time frame: before and the first day after endoscopic treatment
inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta，IL-2R, IL-10
Time frame: before and the first day after endoscopic treatment
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Esophageal and Gastric Varices→
Shanghai Zhongshan Hospital