New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy

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.

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Key information

Conditions

Gastric Cancer Atrophic Gastritis Digestive System Diseases Digestive System Neoplasms Gastritis Gastritis, Atrophic Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammation Intestinal Metaplasia Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

probe-based confocal laser endomicroscopy

Device

all patients will receive pCLE examination

Primary outcomes

The diagnostic accuracy of the new classification system

Time frame: 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

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jul 11, 2013
Registry last updated: May 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed