Barrett's EsophagusPhase 3CEBENCT00487695
Confocal Endomicroscopy for Barrett's Esophagus
A Phase 3 study testing confocal laser endomicroscopy (CLE) and standard endoscopy (EGD) in people with Barrett's Esophagus and Esophageal Adenocarcinoma, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus, Esophageal Adenocarcinoma
- What is being tested?
- confocal laser endomicroscopy (CLE) and standard endoscopy (EGD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Barrett's esophagus or suspected Barrett's-associated neoplasia
- Age > 18
- Able to give informed consent
Who cannot join
- Known advanced malignant disease
- Allergy to the fluorescent contrast agent fluorescein sodium
- Coagulopathy or bleeding disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Barrett's Esophagus, Esophageal Adenocarcinoma
- Being tested
- confocal laser endomicroscopy (CLE), standard endoscopy (EGD)
- Keywords
- Barrett's esophagus, Esophageal adenocarcinoma, Endoscopy, Confocal laser endomicroscopy
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
confocal laser endomicroscopy (CLE)Device
Also called Pentax Confocal Laser Endomicroscope(EC3870KCILK)
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.
standard endoscopy (EGD)Device
Also called Olympus upper endoscope (GIF160)
Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.
| Study group | Role | What they receive |
|---|---|---|
| CLE followed by standard EGD | Active comparator | 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 Receives: Device: confocal laser endomicroscopy (CLE); Device: standard endoscopy (EGD) |
| standard EGD followed by CLE | Active comparator | 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. Receives: Device: confocal laser endomicroscopy (CLE); Device: standard endoscopy (EGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)
The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)
Measured: 6 weeks
Secondary outcomes (5)
Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)
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.
Measured: 6 weeks
Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)
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.
Measured: 6 weeks
Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients
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).
Measured: 6 weeks
Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients
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).
Measured: 6 weeks
Mean Number of Biopsies Taken in Barrett's Surveillance Patients
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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy, Pentax, USA
- Responsible party
- Sponsor
- Investigators
- Marcia I Canto, MD, MHS, Principal investigator, Division of Gastroenterology, Johns Hopkins University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487695
- Sponsor's protocol ID
- NA0002805
- Acronym
- CEBE
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2007
- Last updated
- 22 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dunbar KB, Okolo P 3rd, Montgomery E, Canto MI. Confocal laser endomicroscopy in Barrett's esophagus and endoscopically inapparent Barrett's neoplasia: a prospective, randomized, double-blind, controlled, crossover trial. Gastrointest Endosc. 2009 Oct;70(4):645-54. doi: 10.1016/j.gie.2009.02.009. Epub 2009 Jun 25.
PubMed 19559419
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Associated Neoplasia
- ClinicalTrials.gov ID
- NCT00487695
- Acronym / sponsor ID
- CEBE / NA0002805
- Conditions
- Barrett's Esophagus, Esophageal Adenocarcinoma
- Keywords
- Barrett's esophagus, Esophageal adenocarcinoma, Endoscopy, Confocal laser endomicroscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy, Pentax, USA
- Study start
- Apr 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 19 Jun 2007 (estimated)
- Results
- Posted 17 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLE followed by standard EGD | Active comparator | Device: confocal laser endomicroscopy (CLE), Device: standard endoscopy (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 |
| standard EGD followed by CLE | Active comparator | Device: confocal laser endomicroscopy (CLE), Device: standard endoscopy (EGD)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Barrett's esophagus or suspected Barrett's-associated neoplasia
- Age > 18
- Able to give informed consent
Key exclusion criteria (3 listed)
- Known advanced malignant disease
- Allergy to the fluorescent contrast agent fluorescein sodium
- Coagulopathy or bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| confocal laser endomicroscopy (CLE)Also: Pentax Confocal Laser Endomicroscope(EC3870KCILK)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. | Device | CLE followed by standard EGD, standard EGD followed by CLE |
| standard endoscopy (EGD)Also: Olympus upper endoscope (GIF160)Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus. | Device | CLE followed by standard EGD, standard EGD followed by CLE |
Primary outcome
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)
5 secondary outcomes
Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)
Time frame: 6 weeks
Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)
Time frame: 6 weeks
Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients
Time frame: 6 weeks
Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients
Time frame: 6 weeks
Mean Number of Biopsies Taken in Barrett's Surveillance Patients
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19559419Dunbar KB, Okolo P 3rd, Montgomery E, Canto MI. Confocal laser endomicroscopy in Barrett's esophagus and endoscopically inapparent Barrett's neoplasia: a prospective, randomized, double-blind, controlled, crossover trial. Gastrointest Endosc. 2009 Oct;70(4):645-54. doi: 10.1016/j.gie.2009.02.009. Epub 2009 Jun 25.
- Johns Hopkins University Division of Gastroenterology and Hepatology Website with links to ongoing research and education materials for gastrointestinal diseasesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia I Canto, MD, MHS principal investigator
Division of Gastroenterology, Johns Hopkins University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing confocal laser endomicroscopy (CLE) and standard endoscopy (EGD) in people with Barrett's Esophagus and Esophageal Adenocarcinoma, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00487695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.