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Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia

Sponsor
Shandong University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02534818
Collaborator
(none)
180
Enrollment
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: lower fluorescein sodium dosage 0.02ml/kg
  • Drug: conventional fluorescein sodium dosage 0.1ml/kg
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Diagnostic
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
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

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

Drug: lower fluorescein sodium dosage 0.02ml/kg
fluorescein Sodium Dose of 0.02ml/kg on gastric intestinal metapalsia
Active Comparator: Group 2

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

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

Outcome Measures

Primary Outcome Measures

  1. Difference of the detection rate of gastric intestinal metaplasia between two fluosecein sodium dosage in a per-pateint analysis [six months]

  2. Difference of the detection rate of gastric intestinal metaplasia between two dosage fluosecein sodium in a per-biopsy analysis [six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong China 250012

Sponsors and Collaborators

  • Shandong University

Investigators

  • Study Director: Yanqing Li, PhD. MD, Department of Gastroenterology, Qilu Hospital, Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier:
NCT02534818
Other Study ID Numbers:
  • 2015SDU-QILU-G09
First Posted:
Aug 28, 2015
Last Update Posted:
Nov 10, 2015
Last Verified:
Aug 1, 2015
Additional relevant MeSH terms:
Metaplasia

Study Results

No Results Posted as of Nov 10, 2015