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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02534818

Enrollment

180

Registered

2015-08-28

Start date

2015-06-30

Completion date

Unknown

Last updated

2015-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Intestinal Metaplasia

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.

Interventions

DRUGlower fluorescein sodium dosage 0.02ml/kg

fluorescein Sodium Dose of 0.02ml/kg on gastric intestinal metapalsia

DRUGconventional fluorescein sodium dosage 0.1ml/kg

fluorescein Sodium Dose of 0.1ml/kg on gastric intestinal metapalsia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	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

Countries

China

Contacts

Primary ContactYanqing Li, PhD. MD

qiluliyanqing@gmail.com18678827666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026