Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices

January 4, 2017 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

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

The purpose of the study is to assess the efficiency and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

At present, there is still a controversy about the application of antibiotics in the treatment of patients with non acute hemorrhage of esophageal varices. This study is a randomized controlled trial. Patients randomly enter two treatment groups:

  1. the prophylactic use of antibiotics group

    and

  2. the non-prophylactic use of antibiotics group

Treatment allocation is by block randomization with an equal number for both groups. The incidence of infection after endoscopic treatment will be analyzed.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Shanghai Zhongshan Hospital
        • Principal Investigator:
          • Shiyao Chen, MD
        • Contact:
        • Sub-Investigator:
          • Chengfeng Liu
        • Sub-Investigator:
          • Jie Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
  • age between 18-75 years old;
  • Diagnosis of esophageal gastric varices by gastroscopy
  • Preparation of endoscopic injection of tissue adhesive

Exclusion Criteria:

  • No esophageal gastric varices bleeding history;
  • Esophageal varices or gastric varices which temporarily won't be treated by endoscopic therapy;
  • The cefotiam contraindications: such as allergies, pregnancy etc;
  • Patients with the other malignant tumor except liver cancer;
  • The preoperative diagnosis of infection;
  • The large amount of ascites;
  • The acute bleeding period (< 5 days);
  • Patients refused to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the prophylactic use of antibiotics group
Half an hour before endoscopic treatment, cefotiam 2.0g intravenous
Drug: Cefotiam
Prophylactic use of antibiotics group: Half an hour before endoscopic treatment, cefotiam 2.0g intravenous
Other Names:
  • HaiTiShu
No Intervention: Control
Routine endoscopic examination and treatment. Antibiotics are not used before endoscopic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 2 months
The investigators observe the mortality events during 2 months
2 months
Rebleeding rate
Time Frame: 2 months
Patients will receive an endoscopic examination after patients have been followed up for 2 months.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSY-LCF-2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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