Confocal Endomicroscopy for Barrett's Esophagus (CEBE)
June 17, 2021 updated by: Johns Hopkins University
Confocal Laser Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Associated Neoplasia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
46
Phase
- Phase 3
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
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins Hospital
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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 Names:
Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.
Other Names:
|
|
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.
|
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 Names:
Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
|
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.
|
6 weeks
|
|
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).
|
6 weeks
|
|
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).
|
6 weeks
|
|
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).
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marcia I Canto, MD, MHS, Division of Gastroenterology, Johns Hopkins University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
June 18, 2007
First Submitted That Met QC Criteria
June 18, 2007
First Posted (Estimate)
June 19, 2007
Study Record Updates
Last Update Posted (Actual)
June 22, 2021
Last Update Submitted That Met QC Criteria
June 17, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA0002805
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