Confocal Laser Endomicroscopy
Condition: Digestive System Diseases
MeSH terms: Digestive System Diseases; Gastrointestinal Diseases
Study type: Interventional

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.
    


Intervention name(s): Colonoscopy; Endoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Confocal laser endomicroscopy; cancerous and non-cancerous conditions; tolerance; intravenous fluorescein; Digestive symptoms or disease requiring an endoscopy procedure (upper GI endoscopy or colonoscopy) performed under general anaesthesia