Confocal Laser Endomicroscopy in Digestive Diseases

Digestive System Diseases Clinical Trial

Official title:

Confocal Laser Endomicroscopy in Digestive Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01156064
• Other study ID #: 07CX201
• Status: Recruiting
• Phase: N/A
• First received: June 29, 2010
• Last updated: November 22, 2010
• Start date: August 2008
• Est. completion date: December 2011

Study information

• Verified date: July 2010
• Source: Chinese PLA General Hospital
• Contact: YunSheng Yang, MD
• Phone: 86-10-66939747
• Email: sunny888[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	China PLA General Hospital	Beijing	Bejing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield for neoplasia of CLE vs. standard endoscopy		one year	No
Secondary	Diagnostic yield for neoplasia of CLE vs. NBI/AFI		one year	No