Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2008-08-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case (subjects with digestive diseases)
The investigators cases are subjects with confirmed digestive diseases.
Confocal Laser Endomicroscopy (Pentax/Optiscan)
Confocal laser endomicroscopy is performed using the Pentax/Optiscan confocal endomicroscopy and 5 ml of 10% intravenous fluorescein sodium. Photos of magnified images of the digestive mucosa are taken during the procedure.
Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)
NBI/AFI endoscope offers an alternative light source involve NBI and AFI to view digestive mucosa in real time.
Control
Healthy individuals aged between 18 and 90 years who are asymptomatic for digestive diseases.
Confocal Laser Endomicroscopy (Pentax/Optiscan)
Confocal laser endomicroscopy is performed using the Pentax/Optiscan confocal endomicroscopy and 5 ml of 10% intravenous fluorescein sodium. Photos of magnified images of the digestive mucosa are taken during the procedure.
Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)
NBI/AFI endoscope offers an alternative light source involve NBI and AFI to view digestive mucosa in real time.
Interventions
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Confocal Laser Endomicroscopy (Pentax/Optiscan)
Confocal laser endomicroscopy is performed using the Pentax/Optiscan confocal endomicroscopy and 5 ml of 10% intravenous fluorescein sodium. Photos of magnified images of the digestive mucosa are taken during the procedure.
Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)
NBI/AFI endoscope offers an alternative light source involve NBI and AFI to view digestive mucosa in real time.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included
Exclusion Criteria
* Pregnancy or breast feeding
* Allergy to the fluorescent contrast agent fluorescein sodium
* Coagulopathy or bleeding disorder
* In emergency or life-threatening situations(eg. acute gastrointestinal hemorrhage, and gastrointestinal obstruction or perforation)
* impaired renal function, allergic asthma,
* Cognitively impaired.
* Residing in institutions (eg. prison, extended care facility)
* Have language barriers (eg. illiterate, dysphasic)
18 Years
90 Years
ALL
Yes
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Department of Gastroenterology and Hepatology
Principal Investigators
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Yunsheng Yang, MD
Role: STUDY_CHAIR
Chinese PLA General Hospital
Locations
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China PLA General Hospital
Beijing, Bejing, China
Countries
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Central Contacts
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Facility Contacts
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Jin Huang, MD
Role: primary
References
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Huang J, Yang YS, Lu ZS, Wang SF, Yang J, Yuan J. Detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. World J Gastroenterol. 2015 Jun 14;21(22):6974-81. doi: 10.3748/wjg.v21.i22.6974.
Other Identifiers
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07CX201
Identifier Type: -
Identifier Source: org_study_id