Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia

NCT ID: NCT02534818

Last Updated: 2015-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Brief Summary

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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

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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

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Gastric Intestinal Metaplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

lower fluorescein sodium dosage 0.02ml/kg

Intervention Type DRUG

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

Group 2

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

Group Type ACTIVE_COMPARATOR

conventional fluorescein sodium dosage 0.1ml/kg

Intervention Type DRUG

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

Interventions

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lower fluorescein sodium dosage 0.02ml/kg

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

Intervention Type DRUG

conventional fluorescein sodium dosage 0.1ml/kg

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, PhD. MD

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanqing Li, PhD. MD

Role: CONTACT

18678827666 ext. 82169508

Facility Contacts

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Yanqing Li, MD, PhD

Role: primary

86-531-82169236 ext. 82169508

Other Identifiers

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2015SDU-QILU-G09

Identifier Type: -

Identifier Source: org_study_id

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