Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices (PUoA-EIoTA)

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

Study Overview

• Status: Unknown
• Conditions: Cirrhosis; Gastric Varices
• Intervention / Treatment: Drug: Cefotiam

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.

• Study Type: Interventional
• Enrollment (Anticipated): 912
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • 180 Fenglin Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prophylactic use of antibiotics group; Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous	Drug: Cefotiam; Prophylactic use of antibiotics group：Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous; Other Names: HaiTiShu
No Intervention: On-demand group; Routine endoscopic examination and treatment. Antibiotics are not used during endoscopic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: The First Affiliated Hospital of Anhui Medical University; Beijing Ditan Hospital; Shandong Provincial Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Renmin Hospital of Wuhan University; Second Hospital of Lanzhou University

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: February 4, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 4, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: gastric varices; endoscopic injection of tissue adhesive
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices; Varicose Veins; Anti-Infective Agents; Anti-Bacterial Agents; Cefotiam
• Other Study ID Numbers: CSY-LCF2-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO