New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy

Shandong University

Status: Completed

Conditions: Atrophic Gastritis; Inflammation; Gastric Cancer; Intestinal Metaplasia

Treatments: Device: probe-based confocal laser endomicroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT01896310

2013SDU-QILU-G01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 272 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

272 participants in 1 patient group

pCLE examination

Description:

patients will be prospectively recruited and examined first with high-definition endoscopy (EG-2990i, Pentax, Japan) followed by probe-based confocal laser endomicroscopy

Treatment:

Device: probe-based confocal laser endomicroscopy