Confocal Laser Endomicroscopy

NACompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Digestive System Diseases
Interventions
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.

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.

Trial Locations (5)

13009

Service d'Hépato-Gastroentérologie, Institut Paoli Calmettes, Marseille

31059

CHU de Rangueil, Toulouse

44093

Service d'Hépato-Gastroentérologie, CHU Nantes, Nantes

69495

Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon Sud, Lyon

76031

Service d' hépato-gastro-entérologie, CHU de ROUEN, Rouen

All Listed Sponsors
lead

Nantes University Hospital

OTHER

NCT00561938 - Confocal Laser Endomicroscopy | Biotech Hunter | Biotech Hunter