Confocal Laser Endomicroscopy

Digestive System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561938
• Other study ID #: BRD 07/3-Q
• Status: Completed
• Phase: N/A
• First received: November 20, 2007
• Last updated: February 24, 2009
• Start date: June 2007
• Est. completion date: September 2008

Study information

• Verified date: February 2009
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Procedure:
• Colonoscopy
microscope with a confocal window in its distal part. During ongoing endoscopy, 5 mL of 10% fluorescein (Novartis) will be injected intravenously to perform CLE imaging. In brief, CLE images are obtained few seconds after fluorescein injection by gentle positioning of the confocal window in contact with the digestive mucosa. To stabilize images, some suction can be applied using the operating channel of the endoscope. CLE images ('optical biopsies') will be stored and 1-2 standard biopsies will be performed in the examined area in order to further compare optical and standard biopsies. The overall duration of the procedure will be limited to 1 hour. During and after the procedure, patients will be monitored and surveyed continuously by anaesthesiologist. General tolerance and potential late adverse events will be assessed by the careful inquiry performed 1 month after the procedure by consultant gastroenterologist.
• Endoscopy
After obtaining a written informed consent from all the patients, standard upper GI endoscopy or colonoscopy will be performed under general anaesthesia using a videoendoscope EC-3870 (Pentax), which includes a miniaturized microscope with a confocal window in its distal part. During ongoing endoscopy, 5 mL of 10% fluorescein (Novartis) will be injected intravenously to perform CLE imaging. In brief, CLE images are obtained few seconds after fluorescein injection by gentle positioning of the confocal window in contact with the digestive mucosa. To stabilize images, some suction can be applied using the operating channel of the endoscope. CLE images ('optical biopsies') will be stored and 1-2 standard biopsies will be performed in the examined area in order to further compare optical and standard biopsies. The overall duration of the procedure will be limited to 1 hour. During and after the procedure, patients will be monitored and surveyed continuously by anaesthesiologist.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the tolerance of CLE in terms of frequency and gravity of potential adverse events related to the injection of fluorescein
Secondary	To assess the diagnostic yield of CLE in various clinical conditions (cancerous and non-cancerous diseases) by comparing optical biopsies with standard histology
Secondary	To assess the interobserver agreement for this technique, using a database of optical biopsies created at the end of the study