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

Gastric Intestinal Metaplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01646528
• Other study ID #: 2012SDU-QILU-G01
• Status: Recruiting
• Phase: N/A
• First received: June 28, 2012
• Last updated: July 19, 2012
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2012
• Source: Shandong University
• Contact: Yanqing Li, MD, PhD
• Phone: 86-531-8216923
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Intestinal Metaplasia
• Gastritis, Atrophic
• Metaplasia

Intervention

Procedure:
• CLE examination for upper gastrointestinal tract
Routine upper GI endoscopy plus targeted CLE examination

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	Accuracy of black spots in diagnosis of gastric intestinal metaplasia		up to six months	No