Back to resultsDifferent Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia
Primary Purpose
Gastric Intestinal Metaplasia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
lower fluorescein sodium dosage 0.02ml/kg
conventional fluorescein sodium dosage 0.1ml/kg
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Intestinal Metaplasia
Eligibility Criteria
Inclusion Criteria:
- patients with dyspeptic symptoms and aged 40 years or older
- or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
- or patients with family history of gastric cancer
Exclusion Criteria:
- presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
- presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
- inability to provide informed consent
Sites / Locations
- Department of Gastroenterology, Qilu Hospital, Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
lower fluorescein sodium dosage 0.02ml/kg for gastric intestinal metapalsia
conventional fluorescein sodium dosage 0.1ml/kg for gastric intestinal metapalsia
Outcomes
Primary Outcome Measures
Difference of the detection rate of gastric intestinal metaplasia between two fluosecein sodium dosage in a per-pateint analysis
Difference of the detection rate of gastric intestinal metaplasia between two dosage fluosecein sodium in a per-biopsy analysis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02534818
Brief Title
Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia
Official Title
Conventional Fluorescein Sodium Dosage o.1ml/kg Compared With a Lower Fluorescein Sodium Dosage o.02ml/kg for the Detection of Gastric Intestinal Metaplasia in a High Risk Population: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.
Detailed Description
Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended.
This study aims to compare the diagnostic yield of gastric intestinal metaplasia from two different fluorescein sodium dosage and assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Intestinal Metaplasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
lower fluorescein sodium dosage 0.02ml/kg for gastric intestinal metapalsia
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
conventional fluorescein sodium dosage 0.1ml/kg for gastric intestinal metapalsia
Intervention Type
Drug
Intervention Name(s)
lower fluorescein sodium dosage 0.02ml/kg
Intervention Description
fluorescein Sodium Dose of 0.02ml/kg on gastric intestinal metapalsia
Intervention Type
Drug
Intervention Name(s)
conventional fluorescein sodium dosage 0.1ml/kg
Intervention Description
fluorescein Sodium Dose of 0.1ml/kg on gastric intestinal metapalsia
Primary Outcome Measure Information:
Title
Difference of the detection rate of gastric intestinal metaplasia between two fluosecein sodium dosage in a per-pateint analysis
Time Frame
six months
Title
Difference of the detection rate of gastric intestinal metaplasia between two dosage fluosecein sodium in a per-biopsy analysis
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with dyspeptic symptoms and aged 40 years or older
or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
or patients with family history of gastric cancer
Exclusion Criteria:
presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
inability to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqing Li, PhD. MD
Phone
18678827666
Ext
82169508
Email
qiluliyanqing@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PhD. MD
Organizational Affiliation
Department of Gastroenterology, Qilu Hospital, Shandong University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD, PhD
Phone
86-531-82169236
Ext
82169508
Email
liyanqing@sdu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia
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