ClinicalTrials.gg
Status unknownNCT02693951Updated Jan 6, 2017

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

An interventional study of Cefotiam in Gastric Varices and Cirrhosis, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-06.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastric Varices
  • Cirrhosis

Keywords

  • gastric varices
  • endoscopic injection of tissue adhesive
03

In context

Esophageal and Gastric Varices

171 studies on the registry are indexed under Esophageal and Gastric Varices; 41 are open to participants now.

This study's planned enrollment of 120 is above the median of 107 across 110 interventional studies indexed under Esophageal and Gastric Varices.

Browse Esophageal and Gastric Varices studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 648 studies on the registry; 289 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    the prophylactic use of antibiotics group

    Half an hour before endoscopic treatment, cefotiam 2.0g intravenous

    Drug: Cefotiam

  • No intervention
    Control

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

Interventions

  • DrugCefotiam

    Prophylactic use of antibiotics group: Half an hour before endoscopic treatment, cefotiam 2.0g intravenous

    Also known as: HaiTiShu

06

What researchers measure

Primary outcomes

  1. The incidence of infection after endoscopic treatment

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

    Time frame: 1 week

Secondary outcomes

  1. Rebleeding rate

    Patients will receive an endoscopic examination after patients have been followed up for 2 months.

    Time frame: 2 months

  2. Mortality rate

    The investigators observe the mortality events during 2 months

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • Shanghai Zhongshan Hospital
    Shanghai, Shanghai Municipality 200032, China
    • Chengfeng Liu, Doctor · Contact · 09301010167@fudan.edu.cn · 86-15201927474
    • Shiyao Chen, MD · Principal investigator
    • Chengfeng Liu · Sub investigator
    • Jie Chen · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02693951
Responsible party
Shiyao Chen (Director of department of Gastroenterology, Zhongshan Hospital, Shanghai Zhongshan Hospital) — Principal investigator
First posted
Feb 29, 2016
Start date
Feb 2016
Primary completion
Jan 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Jan 6, 2017

Study contacts

Shiyao Chen, Professor
Contact
chen.shiyao@zs-hospital.sh.cn
86-13601767310
Shiyao Chen, Professor
study director · Shanghai Zhongshan Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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