Confocal Laser Endomicroscopy in Digestive Diseases

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01156064

Enrollment

500

Registered

2010-07-02

Start date

2008-08-31

Completion date

2011-12-31

Last updated

2010-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Diseases

Keywords

Endoscopy, Confocal laser endomicroscopy, Digestive Diseases

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.

Interventions

DEVICEConfocal 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.

DEVICENarrow 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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Diagnostic yield for neoplasia of CLE vs. standard endoscopy	one year

Secondary

Measure	Time frame
Diagnostic yield for neoplasia of CLE vs. NBI/AFI	one year

Countries

China

Contacts

Primary ContactYunSheng Yang, MD

sunny888@medmail.com.cn86-10-66939747

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026