Confocal Laser Endomicroscopy in Digestive Diseases

• Conditions: Digestive System Diseases
• Interventions: Device: Confocal Laser Endomicroscopy (Pentax/Optiscan); Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)

• Registration Number: NCT01156064
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-12
• Study First Submitted: 2010-06-29
• Status Verified: 2010-07
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Last Update Submitted: 2010-11-22
• Last Update Posted: 2010-11-23
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case (subjects with digestive diseases)	Confocal Laser Endomicroscopy (Pentax/Optiscan)	The investigators cases are subjects with confirmed digestive diseases.
Case (subjects with digestive diseases)	Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)	The investigators cases are subjects with confirmed digestive diseases.
Control	Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)	Healthy individuals aged between 18 and 90 years who are asymptomatic for digestive diseases.
Control	Confocal Laser Endomicroscopy (Pentax/Optiscan)	Healthy individuals aged between 18 and 90 years who are asymptomatic for digestive diseases.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield for neoplasia of CLE vs. standard endoscopy	one year

Secondary Outcome Measures

Name	Time	Method
Diagnostic yield for neoplasia of CLE vs. NBI/AFI	one year

Trial Locations

Locations (1)

China PLA General Hospital; 🇨🇳 Beijing, Bejing, China