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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03045783
Other study ID # CSY-LCF2-2016
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 4, 2017
Last updated February 4, 2017
Start date December 2016
Est. completion date July 2019

Study information

Verified date February 2017
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 912
Est. completion date July 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 18 y.o. =age=75 y.o.;

- Diagnosis of esophageal gastric varices by gastroscopy;

- Cirrhotic gastroesophageal variceal bleeding underwent endoscopic injection of tissue adhesive;

Exclusion Criteria:

- age <18 y.o. or age > 75 y.o.;

- 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

Study Design


Intervention

Drug:
Cefotiam
Prophylactic use of antibiotics group:Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous

Locations

Country Name City State
China 180 Fenglin Road Shanghai Shanghai

Sponsors (7)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital Beijing Ditan Hospital, Renmin Hospital of Wuhan University, Shandong Provincial Hospital, The First Affiliated Hospital of Anhui Medical University, The Second People's Hospital of Lanzhou, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of infection after endoscopic treatment Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment 1 week
Secondary Rebleeding rate Patients will be followed up and receive an endoscopic examination after patients have been followed up for 2 months. 2 months
Secondary Mortality rate The investigators observe the mortality events during 2 months 2 months
Secondary All clinical events All clinical events were defined as occurrence rebreeding, ascitic fluid infection, portal vein thrombosis, or death. 2 months
Secondary Serum endotoxin before and the first day after endoscopic treatment
Secondary inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta,IL-2R, IL-10 before and the first day after endoscopic treatment
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