Confocal Endomicroscopy for Barrett's Esophagus (CEBE)

This study has been completed.
Sponsor:
Collaborators:
American Society for Gastrointestinal Endoscopy
Pentax, USA
Information provided by (Responsible Party):
MCanto, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00487695
First received: June 18, 2007
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Confocal Laser Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Associated Neoplasia

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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).

  • Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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).

  • Mean Number of Biopsies Taken in Barrett's Surveillance Patients [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 46
Study Start Date: April 2007
Study Completion Date: September 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Responsible Party: MCanto, Principal Investigator, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00487695     History of Changes
Other Study ID Numbers: NA0002805
Study First Received: June 18, 2007
Results First Received: June 21, 2011
Last Updated: November 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Barrett's esophagus
Esophageal adenocarcinoma
Endoscopy
Confocal laser endomicroscopy

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

ClinicalTrials.gov processed this record on April 15, 2014