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
1 other identifier
observational
272
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 28, 2013
CompletedFirst Posted
Study publicly available on registry
July 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedMay 13, 2014
May 1, 2014
3 months
June 28, 2013
May 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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
Interventions
all patients will receive pCLE examination
Eligibility Criteria
Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University
You may qualify if:
- patients scheduled for pCLE examination
- aged between 18 and 80 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
Biospecimen
endoscopic biopsies will be taken at suspicious lesions
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanqing Li, MD.PhD.
Qilu Hospital of Shandong University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of Qilu Hospital
Study Record Dates
First Submitted
June 28, 2013
First Posted
July 11, 2013
Study Start
June 1, 2013
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
May 13, 2014
Record last verified: 2014-05