Confocal Laser Endomicroscopy

NCT00561938 | Completed

• 1 other identifier: BRD 07/3-Q
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• 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

Interventions

Colonoscopy PROCEDURE

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.

Endoscopy PROCEDURE

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 Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (5)

Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon Sud

Lyon, 69495, France

Location

Service d'Hépato-Gastroentérologie, Institut Paoli Calmettes

Marseille, 13009, France

Location

Service d'Hépato-Gastroentérologie, CHU Nantes

Nantes, 44093, France

Location

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

Rouen, 76031, France

Location

CHU de Rangueil

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Colonoscopy; Endoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jean-Paul Galmiche, PhD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 25, 2009

Record last verified: 2009-02

Locations

FR (5)