Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gastric Intestinal Metaplasia

Intervention / Treatment
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* Drug: lower fluorescein sodium dosage 0.02ml/kg
* Drug: conventional fluorescein sodium dosage 0.1ml/kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>lower fluorescein sodium dosage 0.02ml/kg for gastric intestinal metapalsia | Drug: lower fluorescein sodium dosage 0.02ml/kg<br>* fluorescein Sodium Dose of 0.02ml/kg on gastric intestinal metapalsia<br>|
| Active Comparator: Group 2<br>conventional fluorescein sodium dosage 0.1ml/kg for gastric intestinal metapalsia | Drug: conventional fluorescein sodium dosage 0.1ml/kg<br>* fluorescein Sodium Dose of 0.1ml/kg on gastric intestinal metapalsia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of the detection rate of gastric intestinal metaplasia between two fluosecein sodium dosage in a per-pateint analysis |  | six months | 
| Difference of the detection rate of gastric intestinal metaplasia between two dosage fluosecein sodium in a per-biopsy analysis |  | six months |