Confocal Laser Endomicroscopy

Not Applicable

Completed

• Conditions: Digestive System Diseases

• Registration Number: NCT00561938
• Lead Sponsor: Nantes University Hospital

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

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-24
• Last Update Posted: 2009-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon Sud; 🇫🇷 Lyon, France

Service d'Hépato-Gastroentérologie, Institut Paoli Calmettes; 🇫🇷 Marseille, France

Service d'Hépato-Gastroentérologie, CHU Nantes; 🇫🇷 Nantes, France

Service d' hépato-gastro-entérologie, CHU de ROUEN; 🇫🇷 Rouen, France

CHU de Rangueil; 🇫🇷 Toulouse, France