Clinical trial NCT03045783: Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices
Official title: Efficacy and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Varices
Cirrhosis
Keywords: gastric varices
endoscopic injection of tissue adhesive
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Lanzhou University Second Hospital
name: Beijing Ditan Hospital
name: Shandong Provincial Hospital
name: Renmin Hospital of Wuhan University
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: The First Affiliated Hospital of Anhui Medical University
First posted: 2017-02-07
Enrollment: 912
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of infection after endoscopic treatment
timeFrame: 1 week
Secondary outcomes:
measure: Rebleeding rate
timeFrame: 2 months
measure: Mortality rate
timeFrame: 2 months
measure: All clinical events
timeFrame: 2 months
measure: Serum endotoxin
timeFrame: before and the first day after endoscopic treatment
measure: inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta，IL-2R, IL-10
timeFrame: before and the first day after endoscopic treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
affiliation: Zhongshan Hospital, Fudan University, Shanghai
name: Shiyao CHEN, M.D.
role: PRINCIPAL_INVESTIGATOR
References: