New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy

Gastric Cancer Clinical Trial

Official title:

New Classification of Gastric Pit Patterns and Vessel Architecture Using Probe-based Confocal Laser Endomicroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896310
• Other study ID #: 2013SDU-QILU-G01
• Status: Completed
• Phase: N/A
• First received: June 28, 2013
• Last updated: May 9, 2014
• Start date: June 2013
• Est. completion date: September 2013

Study information

• Verified date: May 2014
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrophic Gastritis
• Gastric Cancer
• Gastritis, Atrophic
• Inflammation
• Intestinal Metaplasia
• Metaplasia

Intervention

Device:
• probe-based confocal laser endomicroscopy
all patients will receive pCLE 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	The diagnostic accuracy of the new classification system	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	3 month	No