Confocal Laser Endomicroscopy in Digestive Diseases

November 22, 2010 updated by: Chinese PLA General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Bejing
      • Beijing, Bejing, China, 100853
        • Recruiting
        • China PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Yunsheng Yang, MD
        • Sub-Investigator:
          • Jin Huang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of a tertiary referral hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case (subjects with digestive diseases)
The investigators cases are subjects with confirmed digestive diseases.
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.
Other Names:
  • Confocal endomicroscopy
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.
Other Names:
  • Narrow Band Imaging(NBI)
  • Auto Fluorescence Imaging(AFI)
Control
Healthy individuals aged between 18 and 90 years who are asymptomatic for digestive diseases.
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.
Other Names:
  • Confocal endomicroscopy
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.
Other Names:
  • Narrow Band Imaging(NBI)
  • Auto Fluorescence Imaging(AFI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic yield for neoplasia of CLE vs. standard endoscopy
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Diagnostic yield for neoplasia of CLE vs. NBI/AFI
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Study Chair: Yunsheng Yang, MD, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

June 29, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (Estimate)

July 2, 2010

Study Record Updates

Last Update Posted (Estimate)

November 23, 2010

Last Update Submitted That Met QC Criteria

November 22, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07CX201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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