Confocal Laser Endomicroscopy
This study has been completed.
Sponsor:
Nantes University Hospital
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00561938
First received: November 20, 2007
Last updated: February 24, 2009
Last verified: February 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Digestive System Diseases |
Procedure: Colonoscopy Procedure: Endoscopy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Confocal Laser Endomicroscopy in the Digestive Tract: A Multicentre French Pilot Study. |
Resource links provided by NLM:
Further study details as provided by Nantes University Hospital:
Primary Outcome Measures:
- 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 Outcome Measures:
- To assess the tolerance of CLE in terms of frequency and gravity of potential adverse events related to the injection of fluorescein
- To assess the diagnostic yield of CLE in various clinical conditions (cancerous and non-cancerous diseases) by comparing optical biopsies with standard histology
- To assess the interobserver agreement for this technique, using a database of optical biopsies created at the end of the study
| Enrollment: | 61 |
| Study Start Date: | June 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561938
Locations
| France | |
| Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon Sud | |
| Lyon, France, 69495 | |
| Service d'Hépato-Gastroentérologie, Institut Paoli Calmettes | |
| Marseille, France, 13009 | |
| Service d'Hépato-Gastroentérologie, CHU Nantes | |
| Nantes, France, 44093 | |
| Service d' hépato-gastro-entérologie, CHU de ROUEN | |
| Rouen, France, 76031 | |
| CHU de Rangueil | |
| Toulouse, France, 31059 | |
Sponsors and Collaborators
Nantes University Hospital
Investigators
| Principal Investigator: | Jean-Paul Galmiche, PhD | Centre Hospitalier Universitaire de Nantes |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00561938 History of Changes |
| Other Study ID Numbers: | BRD 07/3-Q |
| Study First Received: | November 20, 2007 |
| Last Updated: | February 24, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Nantes University Hospital:
|
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 |
Additional relevant MeSH terms:
|
Digestive System Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013