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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02534818
Other study ID # 2015SDU-QILU-G09
Secondary ID
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. completion date
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


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
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