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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Prophylactic use of antibiotics group
    • Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous
  • No Intervention: On-demand group
    • Routine endoscopic examination and treatment. Antibiotics are not used during endoscopic treatment

Clinical Trial Outcome Measures

Primary Measures

  • The incidence of infection after endoscopic treatment
    • Time Frame: 1 week
    • Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment

Secondary Measures

  • Rebleeding rate
    • Time Frame: 2 months
    • Patients will be followed up and receive an endoscopic examination after patients have been followed up for 2 months.
  • Mortality rate
    • Time Frame: 2 months
    • The investigators observe the mortality events during 2 months
  • All clinical events
    • Time Frame: 2 months
    • All clinical events were defined as occurrence rebreeding, ascitic fluid infection, portal vein thrombosis, or death.
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Zhongshan Hospital
  • Collaborator
    • The Second Hospital of Lanzhou University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shiyao Chen, Professor – Shanghai Zhongshan Hospital
  • Overall Official(s)
    • Shiyao CHEN, M.D., Principal Investigator, Zhongshan Hospital, Fudan University, Shanghai

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