Confocal Laser Endomicroscopy

Nantes University Hospital (NUH)

Status: Completed

Conditions: Digestive System Diseases

Treatments: Procedure: Colonoscopy; Procedure: Endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00561938

BRD 07/3-Q

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)