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Confocal Laser Endomicroscopy
This study has been completed.
Study NCT00561938   Information provided by Nantes University Hospital
First Received: November 20, 2007   Last Updated: February 24, 2009   History of Changes

November 20, 2007
February 24, 2009
June 2007
September 2008   (final data collection date for primary outcome measure)
To establish a safe and standardized practice of CLE in France, which should give a possibility, by providing high quality optical biopsies, to perform in vivo diagnosis of different digestive diseases
Same as current
Complete list of historical versions of study NCT00561938 on ClinicalTrials.gov Archive Site
  • To assess the tolerance of CLE in terms of frequency and gravity of potential adverse events related to the injection of fluorescein
  • To assess the diagnostic yield of CLE in various clinical conditions (cancerous and non-cancerous diseases) by comparing optical biopsies with standard histology
  • To assess the interobserver agreement for this technique, using a database of optical biopsies created at the end of the study
Same as current
 
Confocal Laser Endomicroscopy
Confocal Laser Endomicroscopy in the Digestive Tract: A Multicentre French Pilot Study.

Confocal laser endomicroscopy (CLE) is a new diagnostic technique that allows microscopic examination of the digestive mucosa during ongoing endoscopy. Different types of tissue and diseases can be diagnosed immediately, and analysis of the in vivo microarchitecture is helpful to better target standard biopsies and reduce the number of biopsies required. CLE necessitates an intravenous injection of a fluorescent marker, e.g. fluorescein, to obtain 'optical biopsies' with a high level of magnification (up to 1000 fold). To date, more than 1000 endomicroscopy procedures have been performed in the world and different publications have shown the safety, feasibility and excellent diagnostic yield of CLE. No complication related to IV injection of fluorescein has been reported. However, all these data come from a very limited number of expert centres and need to be confirmed and validated at the multicenter level. The aims of this multicenter trial are: 1) to standardize CLE in all centres equipped in France, 2) to ensure the safety of intravenous fluorescein injection, 3) to test the diagnostic value of CLE in various conditions representative of the large spectrum of different cancerous and non-cancerous digestive diseases.

 
 
Interventional
Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Digestive System Diseases
  • Procedure: Colonoscopy
  • Procedure: Endoscopy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
61
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Patient between 18 to 70 years-old
  • Symptoms or disease requiring an upper GI endoscopy or a colonoscopy performed under general anaesthesia
  • Written informed consent obtained

Exclusion criteria:

  • No indication for upper GI endoscopy or colonoscopy
  • Treatment by beta-blockers
  • Coagulopathy
  • Dialysis for impaired renal function
  • Pregnancy or breast-feeding
  • Known allergy to fluorescein
  • Pace-maker
  • Severe cardiac or liver disease
  • Emergency context- Zenker's diverticulum (for upper GI endoscopy) or recently complicated colonic diverticulosis (for colonoscopy)
  • Patient's refusal
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00561938
 
BRD 07/3-Q
Nantes University Hospital
 
Principal Investigator: Jean-Paul Galmiche, PhD Centre Hospitalier Universitaire de Nantes
Nantes University Hospital
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP