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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Yanqing Li, Shandong University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01646528
First Posted: July 20, 2012
Last Update Posted: July 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yanqing Li, Shandong University
  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:


Further study details as provided by Yanqing Li, Shandong University:

Primary Outcome Measures:
  • Accuracy of black spots in diagnosis of gastric intestinal metaplasia [ Time Frame: up to six months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 28, 2012
First Posted: July 20, 2012
Last Update Posted: July 20, 2012
Last Verified: July 2012

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

Additional relevant MeSH terms:
Metaplasia
Pathologic Processes