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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01646528
Other study ID # 2012SDU-QILU-G01
Secondary ID
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


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
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