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Completed

NCT Number: NCT00561938

Confocal Laser Endomicroscopy

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.

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Key information

Conditions

Digestive System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

  1. To assess the tolerance of CLE in terms of frequency and gravity of potential adverse events related to the injection of fluorescein

  2. To assess the diagnostic yield of CLE in various clinical conditions (cancerous and non-cancerous diseases) by comparing optical biopsies with standard histology

  3. To assess the interobserver agreement for this technique, using a database of optical biopsies created at the end of the study

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Confocal Laser Endomicroscopy in the Digestive Tract: A Multicentre French Pilot Study.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 21, 2007
Registry last updated
Feb 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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