Confocal Laser Endomicroscopy in Digestive Diseases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Chinese PLA General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01156064
First received: June 29, 2010
Last updated: November 22, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Digestive System Diseases
Device: Confocal Laser Endomicroscopy (Pentax/Optiscan)
Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Confocal Laser Endomicroscopy in Digestive Diseases

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Diagnostic yield for neoplasia of CLE vs. standard endoscopy [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnostic yield for neoplasia of CLE vs. NBI/AFI [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

biopsy tissue


Estimated Enrollment: 500
Study Start Date: August 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients of a tertiary referral hospital

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156064

Contacts
Contact: YunSheng Yang, MD 86-10-66939747 sunny888@medmail.com.cn

Locations
China, Bejing
China PLA General Hospital Recruiting
Beijing, Bejing, China, 100853
Contact: Jin Huang, MD       lily712@vip.sina.com   
Principal Investigator: Yunsheng Yang, MD         
Sub-Investigator: Jin Huang, MD         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Chair: Yunsheng Yang, MD Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: Yang Yunsheng, Department of Gastroenterology and Hepatology
ClinicalTrials.gov Identifier: NCT01156064     History of Changes
Other Study ID Numbers: 07CX201
Study First Received: June 29, 2010
Last Updated: November 22, 2010
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
Endoscopy
Confocal laser endomicroscopy
Digestive Diseases

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 14, 2014