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

NCT ID: NCT01646528

Last Updated: 2012-07-20

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

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Gastric Intestinal Metaplasia

Keywords

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Gastric Intestinal Metaplasia Confocal Laser Endomicroscopy

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Consecutive patients for CLE examination

CLE examination for upper gastrointestinal tract

Intervention Type PROCEDURE

Routine upper GI endoscopy plus targeted CLE examination

Interventions

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CLE examination for upper gastrointestinal tract

Routine upper GI endoscopy plus targeted CLE examination

Intervention Type PROCEDURE

Other Intervention Names

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confocal endomicroscopy

Eligibility Criteria

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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
Minimum Eligible Age

18 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, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, MD, PhD

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital

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, MD, PhD

Role: CONTACT

Phone: 86-531-8216923

Email: [email protected]

Facility Contacts

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Yanqing Li, MD, PhD

Role: primary

Other Identifiers

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2012SDU-QILU-G01

Identifier Type: -

Identifier Source: org_study_id