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

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:

  • 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

Sites / Locations

  • 180 Fenglin Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prophylactic use of antibiotics group

On-demand group

Arm Description

Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous

Routine endoscopic examination and treatment. Antibiotics are not used during 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 be followed up and receive an endoscopic examination after patients have been followed up for 2 months.
Mortality rate
The investigators observe the mortality events during 2 months
All clinical events
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, portal vein thrombosis, or death.
Serum endotoxin
inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta，IL-2R, IL-10

Full Information

First Posted
January 4, 2017
Last Updated
February 4, 2017
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Second Hospital of Lanzhou University, Beijing Ditan Hospital, Shandong Provincial Hospital, Renmin Hospital of Wuhan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03045783
Brief Title
Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices
Acronym
PUoA-EIoTA
Official Title
Efficacy and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Second Hospital of Lanzhou University, Beijing Ditan Hospital, Shandong Provincial Hospital, Renmin Hospital of Wuhan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Anhui Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

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
Participant
Allocation
Randomized
Enrollment
912 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic use of antibiotics group
Arm Type
Experimental
Arm Description
Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous
Arm Title
On-demand group
Arm Type
No Intervention
Arm Description
Routine endoscopic examination and treatment. Antibiotics are not used during endoscopic treatment
Intervention Type
Drug
Intervention Name(s)
Cefotiam
Other Intervention Name(s)
HaiTiShu
Intervention Description
Prophylactic use of antibiotics group：Prophylactic use of antibiotics during 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 be followed up and 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
Title
All clinical events
Description
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, portal vein thrombosis, or death.
Time Frame
2 months
Title
Serum endotoxin
Time Frame
before and the first day after endoscopic treatment
Title
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

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyao CHEN, M.D.
Organizational Affiliation
Zhongshan Hospital, Fudan University, Shanghai
Official's Role
Principal Investigator
Facility Information:
Facility Name
180 Fenglin Road
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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