Confocal Laser Endomicroscopy

February 24, 2009 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69495
        • Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon Sud
      • Marseille, France, 13009
        • Service d'Hépato-Gastroentérologie, Institut Paoli Calmettes
      • Nantes, France, 44093
        • Service d'Hépato-Gastroentérologie, CHU Nantes
      • Rouen, France, 76031
        • Service d' hépato-gastro-entérologie, CHU de ROUEN
      • Toulouse, France, 31059
        • CHU de Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Jean-Paul Galmiche, PhD, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 21, 2007

Study Record Updates

Last Update Posted (Estimate)

February 25, 2009

Last Update Submitted That Met QC Criteria

February 24, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD 07/3-Q

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Digestive System Diseases

Clinical Trials on Colonoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe