Confocal Laser Endomicroscopy - Tabular View

Tracking Information

First Received Date ^ICMJE

November 20, 2007

Last Updated Date

February 24, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00561938 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Confocal Laser Endomicroscopy

Official Title ^ICMJE

Confocal Laser Endomicroscopy in the Digestive Tract: A Multicentre French Pilot Study.

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Digestive System Diseases

Intervention ^ICMJE

Procedure: Colonoscopy
Procedure: Endoscopy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00561938

Responsible Party

Study ID Numbers ^ICMJE

BRD 07/3-Q

Study Sponsor ^ICMJE

Nantes University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jean-Paul Galmiche, PhD

Centre Hospitalier Universitaire de Nantes

Information Provided By

Nantes University Hospital

Verification Date

February 2009

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