Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia

Phase 4

• Conditions: Gastric Intestinal Metaplasia
• Interventions: Drug: lower fluorescein sodium dosage 0.02ml/kg; Drug: conventional fluorescein sodium dosage 0.1ml/kg

• Registration Number: NCT02534818
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study Start: 2015-06
• Status Verified: 2015-08
• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-08-27
• Study First Posted: 2015-08-28
• Primary Completion: 2015-11
• Last Update Submitted: 2015-11-07
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	lower fluorescein sodium dosage 0.02ml/kg	lower fluorescein sodium dosage 0.02ml/kg for gastric intestinal metapalsia
Group 2	conventional fluorescein sodium dosage 0.1ml/kg	conventional fluorescein sodium dosage 0.1ml/kg for gastric intestinal metapalsia

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China