Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices

Cirrhosis Clinical Trial

— PUoA-EIoTA  

Official title:

Efficacy and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03045783
• Other study ID #: CSY-LCF2-2016
• 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
• 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

Related Conditions & MeSH terms

• Cirrhosis
• Esophageal and Gastric Varices
• Gastric Varices
• Varicose Veins

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