New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy

May 9, 2014 updated by: Yanqing Li, Shandong University

New Classification of Gastric Pit Patterns and Vessel Architecture 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

272

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Principal Investigator: Yanqing Li, MD.PhD., Qilu Hospital, Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

July 5, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Estimate)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013SDU-QILU-G01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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