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Confocal Endomicroscopy for Barrett's Esophagus (CEBE)

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ClinicalTrials.gov Identifier: NCT00487695
Recruitment Status : Completed
First Posted : June 19, 2007
Results First Posted : August 17, 2011
Last Update Posted : March 12, 2018
Sponsor:
Collaborators:
American Society for Gastrointestinal Endoscopy
Pentax, USA
Information provided by (Responsible Party):
Marcia Irene Canto, MD MHS, Johns Hopkins University

Brief Summary:
The purpose of this study is to determine if confocal laser endomicroscopy (CLE) can improve detection of Barrett's esophagus, dysplasia, and early esophageal cancer.

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Esophageal Adenocarcinoma Device: confocal laser endomicroscopy (CLE) Device: standard endoscopy (EGD) Phase 3

Detailed Description:

Barrett's esophagus is a leading cause of esophageal adenocarcinoma. Detection of dysplasia and early cancers in Barrett's esophagus can be challenging, time-consuming and expensive. Small lesions may be difficult to detect with standard endoscopy protocols. Confocal laser endomicroscopy (CLE) is a new type of endoscopy where a small confocal microscope is built into the tip of a standard endoscope. For this study, we are comparing confocal laser endomicroscopy (CLE) with targeted biopsies with standard endoscopy (EGD)and biopsy for Barrett's esophagus to determine if CLE is more effective for detecting dysplasia and cancer.

Participants with Barrett's esophagus in this study undergo 1) CLE with targeted mucosal biopsies (biopsy only taken if CLE shows abnormal tissue) and 2) standard EGD with biopsies. The order of procedures is randomized (some patients have CLE first while others have standard EGD first).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Confocal Laser Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Associated Neoplasia
Study Start Date : April 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: CLE followed by standard EGD
Participants are randomized to have either confocal laser endomicroscopy (CLE) or standard endoscopy (EGD) first. Then 6 weeks later, they have the other procedure. This arm is for patients randomized to CLE followed by standard EGD
Device: confocal laser endomicroscopy (CLE)
Confocal laser endomicroscopy is done by performing standard endoscopy, then using a microscope on the tip of the endoscope to obtain microscopic images of the mucosa. This is done by gently placing the tip of the endoscope on the lining of the esophagus.
Other Name: Pentax Confocal Laser Endomicroscope(EC3870KCILK)
Device: standard endoscopy (EGD)
Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.
Other Name: Olympus upper endoscope (GIF160)
Active Comparator: standard EGD followed by CLE
Patients are randomized to either have standard endoscopy (EGD)or confocal laser endomicroscopy (CLE) first. The second procedure is then completed 6 weeks later. This arm is for patients who had standard endoscopy first.
Device: confocal laser endomicroscopy (CLE)
Confocal laser endomicroscopy is done by performing standard endoscopy, then using a microscope on the tip of the endoscope to obtain microscopic images of the mucosa. This is done by gently placing the tip of the endoscope on the lining of the esophagus.
Other Name: Pentax Confocal Laser Endomicroscope(EC3870KCILK)
Device: standard endoscopy (EGD)
Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.
Other Name: Olympus upper endoscope (GIF160)



Primary Outcome Measures :
  1. Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia) [ Time Frame: 6 weeks ]
    The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)


Secondary Outcome Measures :
  1. Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia) [ Time Frame: 6 weeks ]
    The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients with Barrett's suspected (but not known) neoplasia.

  2. Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia) [ Time Frame: 6 weeks ]
    The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the Barrett's patients with suspected (but not known) neoplasia.

  3. Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients [ Time Frame: 6 weeks ]
    Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. This analysis looks specifically at patients who were referred for surveillance of Barrett's esophagus (no suspected neoplasia).

  4. Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients [ Time Frame: 6 weeks ]
    The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients undergoing surveillance EGD for Barrett's esophagus (no suspected neoplasia).

  5. Mean Number of Biopsies Taken in Barrett's Surveillance Patients [ Time Frame: 6 weeks ]
    The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the patients with Barrett's esophagus in the study who were undergoing surveillance EGD (no suspected neoplasia).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Barrett's esophagus or suspected Barrett's-associated neoplasia
  • Age > 18
  • Able to give informed consent

Exclusion Criteria:

  • Known advanced malignant disease
  • Allergy to the fluorescent contrast agent fluorescein sodium
  • Coagulopathy or bleeding disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487695


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
American Society for Gastrointestinal Endoscopy
Pentax, USA
Investigators
Principal Investigator: Marcia I Canto, MD, MHS Division of Gastroenterology, Johns Hopkins University School of Medicine

Additional Information:
Publications of Results:
Responsible Party: Marcia Irene Canto, MD MHS, Principal Investigator, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00487695     History of Changes
Other Study ID Numbers: NA0002805
First Posted: June 19, 2007    Key Record Dates
Results First Posted: August 17, 2011
Last Update Posted: March 12, 2018
Last Verified: February 2018

Keywords provided by Marcia Irene Canto, MD MHS, Johns Hopkins University:
Barrett's esophagus
Esophageal adenocarcinoma
Endoscopy
Confocal laser endomicroscopy

Additional relevant MeSH terms:
Adenocarcinoma
Barrett Esophagus
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms