NCT02534818

Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Intestinal Metaplasia

Interventions

Type	Name	Description
DRUG	lower fluorescein sodium dosage 0.02ml/kg	fluorescein Sodium Dose of 0.02ml/kg on gastric intestinal metapalsia
DRUG	conventional fluorescein sodium dosage 0.1ml/kg	fluorescein Sodium Dose of 0.1ml/kg on gastric intestinal metapalsia

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-11-01
• First posted: 2015-08-28
• Last updated: 2015-11-10

Locations

1 site across 1 country: China