Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia

Gastric Intestinal Metaplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02534818
• Other study ID #: 2015SDU-QILU-G09
• Status: Recruiting
• Phase: Phase 4
• First received: August 25, 2015
• Last updated: November 7, 2015
• Start date: June 2015

Study information

• Verified date: August 2015
• Source: Shandong University
• Contact: Yanqing Li, PhD. MD
• Phone: 18678827666
• Email: qiluliyanqing[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastric Intestinal Metaplasia
• Gastritis, Atrophic
• Metaplasia

Intervention

Drug:
• lower fluorescein sodium dosage 0.02ml/kg
fluorescein Sodium Dose of 0.02ml/kg on gastric intestinal metapalsia
• conventional fluorescein sodium dosage 0.1ml/kg
fluorescein Sodium Dose of 0.1ml/kg on gastric intestinal metapalsia

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of the detection rate of gastric intestinal metaplasia between two fluosecein sodium dosage in a per-pateint analysis		six months	No
Primary	Difference of the detection rate of gastric intestinal metaplasia between two dosage fluosecein sodium in a per-biopsy analysis		six months	No