Gastric Cancer Clinical Trial
Official title:
New Classification of Gastric Pit Patterns and Vessel Architecture Using Probe-based Confocal Laser Endomicroscopy
Verified date | May 2014 |
Source | Shandong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 272 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Department of Gastroenterology, Qilu Hospital, Shandong University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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