New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01896310

Enrollment

272

Registered

2013-07-11

Start date

2013-06-30

Completion date

2013-09-30

Last updated

2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Intestinal Metaplasia, Atrophic Gastritis, Inflammation

Brief 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.

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.

Interventions

DEVICEprobe-based confocal laser endomicroscopy

all patients will receive pCLE examination

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The diagnostic accuracy of the new classification system	3 month	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026