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The Value of Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy

The Value of Mesenchymal Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01646528
Enrollment
30
Registered
2012-07-20
Start date
2012-06-30
Completion date
2012-12-31
Last updated
2012-07-20

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

Conditions

Gastric Intestinal Metaplasia

Keywords

Gastric Intestinal Metaplasia, Confocal Laser Endomicroscopy

Brief summary

The study aims to: 1. Explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy (CLE). 2. Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in patients with gastric mesenchymal black spot during CLE imaging.

Detailed description

Gastric intestinal metaplasia (GIM) is confirmed to be a risk factor that may lead to the development of intestinal type gastric cancer. Previous study has shown that confocal laser endomicroscopy promising in the diagnosis of GIM. The investigators have found an elevated incidence of mesenchymal black spots in patients with GIM during previous CLE imaging. This study aims to explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy.

Interventions

PROCEDURECLE examination for upper gastrointestinal tract

Routine upper GI endoscopy plus targeted CLE examination

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients will include male or female aged between 18 and 80 years with indications for upper-endoscopy , but without any disease of heart, liver or kidney.

Exclusion criteria

* Patients who are allergic to fluorescein sodium * Patients who are unwilling to sign or give the informed consent form * Patients with impaired cardiac, liver or renal function * Patients with coagulopathy * Patients with pregnancy or breastfeeding

Design outcomes

Primary

MeasureTime frame
Accuracy of black spots in diagnosis of gastric intestinal metaplasiaup to six months

Countries

China

Contacts

Primary ContactYanqing Li, MD, PhD
liyanqing@sdu.edu.cn86-531-8216923

Outcome results

None listed

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