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

This study is currently recruiting participants.
Verified July 2012 by Shandong University
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University
ClinicalTrials.gov Identifier:
NCT01646528
First received: June 28, 2012
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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.

Condition Intervention
Gastric Intestinal Metaplasia
 Procedure: CLE examination for upper gastrointestinal tract

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Value of Mesenchymal Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy

Resource links provided by NLM:

MedlinePlus related topics: Rashes
U.S. FDA Resources

Further study details as provided by Shandong University:

Primary Outcome Measures:
  • Accuracy of black spots in diagnosis of gastric intestinal metaplasia [ Time Frame: up to six months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Taken biopsies during endoscopy


Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Consecutive patients for CLE examination Procedure: CLE examination for upper gastrointestinal tract
Routine upper GI endoscopy plus targeted CLE examination
Other Name: confocal endomicroscopy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients without any disease of heart, liver or kidney.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646528

Contacts
Contact: Yanqing Li, MD, PhD 86-531-8216923 ext 82169508 liyanqing@sdu.edu.cn

Locations
China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, MD, PhD     86-531-82169236 ext 82169508     liyanqing@sdu.edu.cn    
Sponsors and Collaborators
Shandong University
Investigators
Study Director: Yanqing Li, MD, PhD Department of Gastroenterology, Qilu Hospital
  More Information

No publications provided

Responsible Party: Yanqing Li, Vice President, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University, Shandong University
ClinicalTrials.gov Identifier: NCT01646528     History of Changes
Other Study ID Numbers: 2012SDU-QILU-G01
Study First Received: June 28, 2012
Last Updated: July 19, 2012
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
Gastric Intestinal Metaplasia
Confocal Laser Endomicroscopy

Additional relevant MeSH terms:
Metaplasia
Gastritis, Atrophic
Pathologic Processes
Gastritis
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 21, 2013