New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy

This study is currently recruiting participants.
Verified June 2013 by Shandong University
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University
ClinicalTrials.gov Identifier:
NCT01896310
First received: June 28, 2013
Last updated: July 5, 2013
Last verified: June 2013
  Purpose

The aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.


Condition Intervention
Gastric Cancer
Intestinal Metaplasia
Atrophic Gastritis
Inflammation
Device: probe-based confocal laser endomicroscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Classification of Gastric Pit Patterns and Vessel Architecture Using Probe-based Confocal Laser Endomicroscopy

Resource links provided by NLM:


Further study details as provided by Shandong University:

Primary Outcome Measures:
  • The diagnostic accuracy of the new classification system [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of the new classification of gastric pit patterns and vessel architecture using probe-based confocal laser endomicroscopy


Biospecimen Retention:   Samples With DNA

endoscopic biopsies will be taken at suspicious lesions


Estimated Enrollment: 500
Study Start Date: June 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pCLE examination
patients will be prospectively recruited and examined first with high-definition endoscopy (EG-2990i, Pentax, Japan) followed by probe-based confocal laser endomicroscopy
Device: probe-based confocal laser endomicroscopy
all patients will receive pCLE examination

Detailed Description:

Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device which allows the application of laser microscopy with any conventional endoscope and mosaic imaging. Previous studies have demonstrated its application in various GI diseases, including Barrett's esophagus, colonic adenoma, ulcerative colitis, and etc. However, limited data are provided on exploring the application of pCLE in the stomach. Therefore, the aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.

  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

Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University

Criteria

Inclusion Criteria:

  • patients scheduled for pCLE examination
  • aged between 18 and 80 years old

Exclusion Criteria:

  • Esophageal, gastric or duodenal cancer or other malignancy
  • History of upper GI tract surgery
  • Coagulopathy or bleeding disorders
  • Allergy to fluorescein sodium
  • Pregnant or breast-feeding (for females)
  • Impaired renal function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01896310

Contacts
Contact: Yanqing Li, PhD. MD. 86-531-82169236 ext 82169508 308077828@qq.com

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    308077828@qq.com   
Sponsors and Collaborators
Shandong University
Investigators
Principal Investigator: Yanqing Li, MD.PhD. Qilu Hospital, Shandong University
  More Information

No publications provided

Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT01896310     History of Changes
Other Study ID Numbers: 2013SDU-QILU-G01
Study First Received: June 28, 2013
Last Updated: July 5, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Gastritis
Gastritis, Atrophic
Inflammation
Stomach Neoplasms
Metaplasia
Atrophy
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 16, 2014