Clinical trial NCT00561938: Confocal Laser Endomicroscopy
Official title: Confocal Laser Endomicroscopy in the Digestive Tract: A Multicentre French Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive System Diseases
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
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2007-11-21
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: 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 outcomes:
measure: To assess the tolerance of CLE in terms of frequency and gravity of potential adverse events related to the injection of fluorescein
measure: To assess the diagnostic yield of CLE in various clinical conditions (cancerous and non-cancerous diseases) by comparing optical biopsies with standard histology
measure: To assess the interobserver agreement for this technique, using a database of optical biopsies created at the end of the study
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon Sud
city: Marseille
country: France
facility: Service d'Hépato-Gastroentérologie, Institut Paoli Calmettes
city: Nantes
country: France
facility: Service d'Hépato-Gastroentérologie, CHU Nantes
city: Rouen
country: France
facility: Service d' hépato-gastro-entérologie, CHU de ROUEN
city: Toulouse
country: France
facility: CHU de Rangueil
Study officials:
affiliation: Nantes University Hospital
name: Jean-Paul Galmiche, PhD
role: PRINCIPAL_INVESTIGATOR
References: