Confocal Laser Endomicroscopy

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00561938
First received: November 20, 2007
Last updated: February 24, 2009
Last verified: February 2009
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Nantes University Hospital
  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 July 28, 2014