Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Gastric Intestinal Metaplasia

Treatments: Drug: lower fluorescein sodium dosage 0.02ml/kg; Drug: conventional fluorescein sodium dosage 0.1ml/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT02534818

2015SDU-QILU-G09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Group 1

Experimental group

Description:

lower fluorescein sodium dosage 0.02ml/kg for gastric intestinal metapalsia

Treatment:

Drug: lower fluorescein sodium dosage 0.02ml/kg

Group 2

Active Comparator group

Description:

conventional fluorescein sodium dosage 0.1ml/kg for gastric intestinal metapalsia

Treatment:

Drug: conventional fluorescein sodium dosage 0.1ml/kg