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

Primary Purpose

Gastric Varices, Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cefotiam
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Varices focused on measuring gastric varices, endoscopic injection of tissue adhesive

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

the prophylactic use of antibiotics group

Control

Arm Description

Half an hour before endoscopic treatment, cefotiam 2.0g intravenous

Routine endoscopic examination and treatment. Antibiotics are not used before endoscopic treatment

Outcomes

Primary Outcome Measures

The incidence of infection after endoscopic treatment
Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment.

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2016
Last Updated
January 4, 2017
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02693951
Brief Title
Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices
Official Title
Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: the prophylactic use of antibiotics group and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Varices, Cirrhosis
Keywords
gastric varices, endoscopic injection of tissue adhesive

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the prophylactic use of antibiotics group
Arm Type
Experimental
Arm Description
Half an hour before endoscopic treatment, cefotiam 2.0g intravenous
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine endoscopic examination and treatment. Antibiotics are not used before endoscopic treatment
Intervention Type
Drug
Intervention Name(s)
Cefotiam
Other Intervention Name(s)
HaiTiShu
Intervention Description
Prophylactic use of antibiotics group: Half an hour before endoscopic treatment, cefotiam 2.0g intravenous
Primary Outcome Measure Information:
Title
The incidence of infection after endoscopic treatment
Description
Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Rebleeding rate
Description
Patients will receive an endoscopic examination after patients have been followed up for 2 months.
Time Frame
2 months
Title
Mortality rate
Description
The investigators observe the mortality events during 2 months
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyao Chen, Professor
Phone
86-13601767310
Email
chen.shiyao@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyao Chen, Professor
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengfeng Liu, Doctor
Phone
86-15201927474
Email
09301010167@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Shiyao Chen, MD
First Name & Middle Initial & Last Name & Degree
Chengfeng Liu
First Name & Middle Initial & Last Name & Degree
Jie Chen

12. IPD Sharing Statement

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

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