Confocal Laser Endomicroscopy in Digestive Diseases

Study Overview
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Brief Summary
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Confocal laser endomicroscopy (CLE) is a newly endoscopic device that enables microscopic view of the digestive tract. The purpose of this study is to determine if confocal laser endomicroscopy can improve detection of digestive disease include inflammation, dysplasia, and early cancer, and if confocal laser endomicroscopy has competitive advantage, compared with other device such as Narrow Band Imaging and Autofluoresecence Imaging.

Detailed Description
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Advances in endoscopy have led to imagining of the details of digestive mucosa. Novel techniques such as Narrow Band Imaging (NBI) assisted magnification endoscopy, Auto Fluorescence Imaging (AFI) or confocal laser endomicroscopy could, however, improve the endoscopic detection.In this research we describe the combined use of these three techniques in patients with digestive disease.

Official Title
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Confocal Laser Endomicroscopy in Digestive Diseases

Conditions
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Digestive System Diseases

Intervention / Treatment
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* Device: Confocal Laser Endomicroscopy (Pentax/Optiscan)
* Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects over 18 years of age Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included Exclusion Criteria: Under 18 years of age. 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case (subjects with digestive diseases)<br>The investigators cases are subjects with confirmed digestive diseases. | Device: Confocal Laser Endomicroscopy (Pentax/Optiscan)<br>* 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.<br>* Other names: Confocal endomicroscopy;Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)<br>* NBI/AFI endoscope offers an alternative light source involve NBI and AFI to view digestive mucosa in real time.<br>* Other names: Auto Fluorescence Imaging(AFI);|
| Control<br>Healthy individuals aged between 18 and 90 years who are asymptomatic for digestive diseases. | Device: Confocal Laser Endomicroscopy (Pentax/Optiscan)<br>* 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.<br>* Other names: Confocal endomicroscopy;Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)<br>* NBI/AFI endoscope offers an alternative light source involve NBI and AFI to view digestive mucosa in real time.<br>* Other names: Auto Fluorescence Imaging(AFI);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield for neoplasia of CLE vs. standard endoscopy |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield for neoplasia of CLE vs. NBI/AFI |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopy, Confocal laser endomicroscopy, Digestive Diseases