Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia
NCT ID: NCT02534818
Last Updated: 2015-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
180 participants
INTERVENTIONAL
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Group 1
lower fluorescein sodium dosage 0.02ml/kg for gastric intestinal metapalsia
lower fluorescein sodium dosage 0.02ml/kg
fluorescein Sodium Dose of 0.02ml/kg on gastric intestinal metapalsia
Group 2
conventional fluorescein sodium dosage 0.1ml/kg for gastric intestinal metapalsia
conventional fluorescein sodium dosage 0.1ml/kg
fluorescein Sodium Dose of 0.1ml/kg on gastric intestinal metapalsia
Interventions
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lower fluorescein sodium dosage 0.02ml/kg
fluorescein Sodium Dose of 0.02ml/kg on gastric intestinal metapalsia
conventional fluorescein sodium dosage 0.1ml/kg
fluorescein Sodium Dose of 0.1ml/kg on gastric intestinal metapalsia
Eligibility Criteria
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Inclusion Criteria
* 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 conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
* inability to provide informed consent
40 Years
80 Years
ALL
No
Sponsors
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Shandong University
OTHER
Responsible Party
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Yanqing Li
Vice president of Qilu Hospital
Principal Investigators
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Yanqing Li, PhD. MD
Role: STUDY_DIRECTOR
Department of Gastroenterology, Qilu Hospital, Shandong University
Locations
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Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015SDU-QILU-G09
Identifier Type: -
Identifier Source: org_study_id
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