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

Shandong University

Status: Unknown

Conditions: Gastric Intestinal Metaplasia

Treatments: Procedure: CLE examination for upper gastrointestinal tract

Study type: Observational

Funder types: Other

Identifiers

NCT01646528

2012SDU-QILU-G01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Consecutive patients for CLE examination

Treatment:

Procedure: CLE examination for upper gastrointestinal tract