Barrett's Esophagus, Esophageal Intraepithelial NeoplasiaCEBENCT01124214
Confocal Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Early Esophageal Cancer(CEBE Study)
A study testing endomicroscopy in people with Barrett's Esophagus, Esophageal Intraepithelial Neoplasia, run by Johns Hopkins University at 4 sites in 2 countries.
Trial summary
Endomicroscopy (EM) can improve the diagnosis Barrett's esophagus (BE) and some early esophageal cancers (Intra Epithelial Neoplasia (IEN)). EM provides optical biopsies comparable to standard histology. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett's Esophagus, Esophageal Intraepithelial Neoplasia
- What is being tested?
- endomicroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surveillance of Barrett's esophagus or suspected or known BE associated neoplasia
Who cannot join
- Allergy or prior reaction to the fluorescent contrast agent fluorescein sodium
- Unable to give informed consent.
- Pregnant or breastfeeding women
- Known advanced adenocarcinoma in the esophagus
- Dysplastic or suspected malignant esophageal lesion 0 BE lesions 2 cm or more in size with Paris classification of 0-Ip (polypoid), 0-Is (protruding sessile), 0-IIa (flat elevated), or 0-IIb (flat)
- Lesions of any size with Paris 0-IIc (superficial shallow depressed) or 0-III (excavated)
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- Acute gastrointestinal bleeding
- Coagulopathy defined by Partial Thromboplastin Time (PTT) > 50 sec, or International Normalized Ratio (INR) > 2.0, platelets < 40,000, or on chronic anticoagulation
- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy.
- History of a severe allergic reaction (anaphylaxis)
- Known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02199
Mount Sinai School of Medicine
New York, New York, 10029
University of Pennsylvania Medical Institution
Philadelphia, Pennsylvania, 19104
About this study
Official title: In Vivo Endomicroscopy (EM) for Improved Diagnosis of Barrett's Esophagus (BE) and Associated Neoplasia: A Multicenter Randomized Controlled Trial of Diagnostic Yield and Clinical Impact
Endomicroscopy (EM) can improve the diagnosis Barrett's esophagus (BE) and some early esophageal cancers (Intra Epithelial Neoplasia (IEN)). EM provides optical biopsies comparable to standard histology. Specifically, EM allows targeted biopsy rather than random mucosal biopsy during routine endoscopic surveillance of BE or evaluation EIN, which will improve the diagnostic yield of mucosal samples for BE IEN. Furthermore, when combined with high resolution endoscopy, EM may improve the overall in vivo detection of IEN in lesions as well as flat mucosa.
EM will provide accurate place and size of IEN which will impact the physician's decision to biopsy or perform endoscopic mucosal resection (EMR). This could potentially minimize the number of unnecessary biopsies and as well as enable the physician to perform EMR at the time of the initial examination, rather than delaying endoscopic treatment after the pathology is available. This study is important because it will validate single center studies supporting the routine use of EM for screening and surveillance of BE.
Read the detailed description
The central hypothesis is that endomicroscopy (EM) can improve the efficiency of the endoscopic diagnosis of Barrett's esophagus (BE) and associated Intraepithelial neoplasia(IEN), providing in-vivo optical biopsies comparable to standard histology. Specifically, EM will enable targeted biopsy rather than random mucosal biopsy during routine endoscopic surveillance of BE or endoscopic evaluation of patients with suspected or proven unlocalized IEN, which will improve the diagnostic yield of mucosal samples for BE IEN. Furthermore, when combined with high resolution endoscopy, EM may improve the overall in vivo detection of IEN in lesions as well as flat mucosa.
The investigators also hypothesize that EM will provide additional accurate information regarding the presence of IEN that will impact upon the physician's decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR). This could potentially minimize the number of unnecessary biopsies and as well as enable the physician to perform EMR at the time of the initial examination, rather than delaying endoscopic treatment to another procedure after the pathology from the mucosal biopsies are available. This study is important because it will validate single center studies supporting the routine use of EM for screening and surveillance of BE.
- Being tested
- endomicroscopy
- Keywords
- Barrett's, BE, esophageal cancer, esophageal dysplasia
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endomicroscopyProcedure or surgery
Also called Confocal Laser Microscopy (CLE), EM, confocal microscopy
endomicroscopy scope lens has capability to optically evaluate mucosa/submucosa as a microscope
| Study group | Role | What they receive |
|---|---|---|
| High Resolution endoscopy (HRE) | No intervention | Standard of care, high resolution endoscopy surveillance/ evaluation of BE and or IEN |
| Endomicroscopy (EM) | Active comparator | Standard of care, high resolution endoscopy surveillance/ evaluation of BE and or IEN and endomicroscopy esophageal evaluation Receives: Procedure: endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare diagnostic yield
Compare the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRE plus EM with directed biopsy (HRE-EM-DB) over HRE with directed biopsy of all mucosal lesions followed by random biopsy (HRE-DB-RB) to diagnose BE in flat mucosa and mucosal lesions
The mean diagnostic yield for IEN will be calculated (number of mucosal biopsies and EMR specimens with High Grade Dysplasia (HGD) or Carcinoma (CA) divided by total number of mucosal biopsies obtained) by group and compared, using a chi square or Fisher's exact test for independent groups, depending on the distribution of the data.
Measured: 1 year
Secondary outcomes (2)
assess clinical impact of EM
To prospectively assess the potential clinical impact of EM on the diagnosis and endoscopic surveillance of BE by determining if EM alters the decision to biopsy or EMR and change the total of biopsies per procedure.
Measured: 1 year
compare the specificity and sensitivity of HRE with EM
To compare the performance (sensitivity and specificity) characteristics of HRE-EM-DB with HRE-RB for prediction of BE/IEN using the pathologic diagnosis of mucosal biopsies the as the reference standard.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett's Esophagus, Esophageal Intraepithelial NeoplasiaStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy, Pentax Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Marcia I Canto, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124214
- Sponsor's protocol ID
- NA_00025471
- Acronym
- CEBE
- Status last verified
- May 2023
- First submitted
- 13 May 2010
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Canto MI, Anandasabapathy S, Brugge W, Falk GW, Dunbar KB, Zhang Z, Woods K, Almario JA, Schell U, Goldblum J, Maitra A, Montgomery E, Kiesslich R; Confocal Endomicroscopy for Barrett's Esophagus or Confocal Endomicroscopy for Barrett's Esophagus (CEBE) Trial Group. In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia: a multicenter international randomized controlled trial (with video). Gastrointest Endosc. 2014 Feb;79(2):211-21. doi: 10.1016/j.gie.2013.09.020. Epub 2013 Nov 9.
PubMed 24219822
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Endomicroscopy (EM) for Improved Diagnosis of Barrett's Esophagus (BE) and Associated Neoplasia: A Multicenter Randomized Controlled Trial of Diagnostic Yield and Clinical Impact
- ClinicalTrials.gov ID
- NCT01124214
- Acronym / sponsor ID
- CEBE / NA_00025471
- Keywords
- Barrett's, BE, esophageal cancer, esophageal dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy, Pentax Medical Corporation
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endomicroscopy (EM) can improve the diagnosis Barrett's esophagus (BE) and some early esophageal cancers (Intra Epithelial Neoplasia (IEN)). EM provides optical biopsies comparable to standard histology. Specifically, EM allows targeted biopsy rather than random mucosal biopsy during routine endoscopic surveillance of BE or evaluation EIN, which will improve the diagnostic yield of mucosal samples for BE IEN. Furthermore, when combined with high resolution endoscopy, EM may improve the overall in vivo detection of IEN in lesions as well as flat mucosa.
EM will provide accurate place and size of IEN which will impact the physician's decision to biopsy or perform endoscopic mucosal resection (EMR). This could potentially minimize the number of unnecessary biopsies and as well as enable the physician to perform EMR at the time of the initial examination, rather than delaying endoscopic treatment after the pathology is available. This study is important because it will validate single center studies supporting the routine use of EM for screening and surveillance of BE.
Detailed description
The central hypothesis is that endomicroscopy (EM) can improve the efficiency of the endoscopic diagnosis of Barrett's esophagus (BE) and associated Intraepithelial neoplasia(IEN), providing in-vivo optical biopsies comparable to standard histology. Specifically, EM will enable targeted biopsy rather than random mucosal biopsy during routine endoscopic surveillance of BE or endoscopic evaluation of patients with suspected or proven unlocalized IEN, which will improve the diagnostic yield of mucosal samples for BE IEN. Furthermore, when combined with high resolution endoscopy, EM may improve the overall in vivo detection of IEN in lesions as well as flat mucosa.
The investigators also hypothesize that EM will provide additional accurate information regarding the presence of IEN that will impact upon the physician's decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR). This could potentially minimize the number of unnecessary biopsies and as well as enable the physician to perform EMR at the time of the initial examination, rather than delaying endoscopic treatment to another procedure after the pathology from the mucosal biopsies are available. This study is important because it will validate single center studies supporting the routine use of EM for screening and surveillance of BE.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Resolution endoscopy (HRE) | No intervention | –Standard of care, high resolution endoscopy surveillance/ evaluation of BE and or IEN |
| Endomicroscopy (EM) | Active comparator | Procedure: endomicroscopyStandard of care, high resolution endoscopy surveillance/ evaluation of BE and or IEN and endomicroscopy esophageal evaluation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Surveillance of Barrett's esophagus or suspected or known BE associated neoplasia
Key exclusion criteria (11 listed)
- Allergy or prior reaction to the fluorescent contrast agent fluorescein sodium
- Unable to give informed consent.
- Pregnant or breastfeeding women
- Known advanced adenocarcinoma in the esophagus
- Dysplastic or suspected malignant esophageal lesion 0 BE lesions 2 cm or more in size with Paris classification of 0-Ip (polypoid), 0-Is (protruding sessile), 0-IIa (flat elevated), or 0-IIb (flat)
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 |
|---|---|---|
| endomicroscopyAlso: Confocal Laser Microscopy (CLE), EM, confocal microscopyendomicroscopy scope lens has capability to optically evaluate mucosa/submucosa as a microscope | Procedure or surgery | Endomicroscopy (EM) |
Primary outcome
compare diagnostic yield
Time frame: 1 year
Compare the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRE plus EM with directed biopsy (HRE-EM-DB) over HRE with directed biopsy of all mucosal lesions followed by random biopsy (HRE-DB-RB) to diagnose BE in flat mucosa and mucosal lesions The mean diagnostic yield for IEN will be calculated (number of mucosal biopsies and EMR specimens with High Grade Dysplasia (HGD) or Carcinoma (CA) divided by total number of mucosal biopsies obtained) by group and compared, using a chi square or Fisher's exact test for independent groups, depending on the distribution of the data.
2 secondary outcomes
assess clinical impact of EM
Time frame: 1 year
compare the specificity and sensitivity of HRE with EM
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Background: PubMed 24219822Canto MI, Anandasabapathy S, Brugge W, Falk GW, Dunbar KB, Zhang Z, Woods K, Almario JA, Schell U, Goldblum J, Maitra A, Montgomery E, Kiesslich R; Confocal Endomicroscopy for Barrett's Esophagus or Confocal Endomicroscopy for Barrett's Esophagus (CEBE) Trial Group. In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia: a multicenter international randomized controlled trial (with video). Gastrointest Endosc. 2014 Feb;79(2):211-21. doi: 10.1016/j.gie.2013.09.020. Epub 2013 Nov 9.
- Johns Hopkins GI website, Barrett's esophagus sectionLink 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 principal investigator
Johns Hopkins University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endomicroscopy in people with Barrett's Esophagus, Esophageal Intraepithelial Neoplasia, run by Johns Hopkins University at 4 sites in 2 countries.
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 1 inclusion and 11 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
compare diagnostic yield (time frame: 1 year). 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 NCT01124214, 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 17 May 2023.