Confocal Laser Endomicroscopy

NCT ID: NCT00561938

Last Updated: 2009-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-09-30

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.

Conditions

Digestive System Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Jean-Paul Galmiche, PhD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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

Countries

France

Other Identifiers

BRD 07/3-Q

Identifier Type: -

Identifier Source: org_study_id