Confocal Laser Endomicroscopy in Digestive Diseases

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Digestive System Diseases

Treatments: Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus); Device: Confocal Laser Endomicroscopy (Pentax/Optiscan)

Study type: Observational

Funder types: Other

Identifiers

NCT01156064

07CX201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

500 participants in 2 patient groups

Case (subjects with digestive diseases)

Description:

The investigators cases are subjects with confirmed digestive diseases.

Treatment:

Device: Confocal Laser Endomicroscopy (Pentax/Optiscan)

Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)

Control

Description:

Healthy individuals aged between 18 and 90 years who are asymptomatic for digestive diseases.

Treatment:

Device: Confocal Laser Endomicroscopy (Pentax/Optiscan)

Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)