Confocal Laser Endomicroscopy in Digestive Diseases

NCT ID: NCT01156064

Last Updated: 2010-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-12-31

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.

Conditions

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Digestive System Diseases

Keywords

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Endoscopy Confocal laser endomicroscopy Digestive Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case (subjects with digestive diseases)

The investigators cases are subjects with confirmed digestive diseases.

Confocal Laser Endomicroscopy (Pentax/Optiscan)

Intervention Type DEVICE

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)

Intervention Type DEVICE

NBI/AFI endoscope offers an alternative light source involve NBI and AFI to view digestive mucosa in real time.

Control

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

Confocal Laser Endomicroscopy (Pentax/Optiscan)

Intervention Type DEVICE

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)

Intervention Type DEVICE

NBI/AFI endoscope offers an alternative light source involve NBI and AFI to view digestive mucosa in real time.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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Confocal endomicroscopy Narrow Band Imaging(NBI) Auto Fluorescence Imaging(AFI)

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Gastroenterology and Hepatology

Principal Investigators

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Yunsheng Yang, MD

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

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China PLA General Hospital

Beijing, Bejing, China

Site Status RECRUITING

Countries

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China

Central Contacts

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YunSheng Yang, MD

Role: CONTACT

Phone: 86-10-66939747

Email: [email protected]

Facility Contacts

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Jin Huang, MD

Role: primary

References

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Huang J, Yang YS, Lu ZS, Wang SF, Yang J, Yuan J. Detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. World J Gastroenterol. 2015 Jun 14;21(22):6974-81. doi: 10.3748/wjg.v21.i22.6974.

Reference Type DERIVED
PMID: 26078575 (View on PubMed)

Other Identifiers

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07CX201

Identifier Type: -

Identifier Source: org_study_id