Barrett'S-associated DysplasiaNCT01862666
A Comparison of Volumetric Laser Endomicroscopy (VLE) and Endoscopic Mucosal Resection (EMR) in Patients With Barrett's Dysplasia or Intramucosal Adenocarcinoma
An observational study of Barrett'S-associated Dysplasia and Intramucosal Adenocarcinoma, run by NinePoint Medical at 1 site in Netherlands.
Trial summary
Barrett's esophagus (BE) is a pre-neoplastic condition formed by the metaplasia of the normal squamous mucosa of the distal esophagus into a specialized intestinal mucosa. Its development is mostly associated with chronic injury from gastroesophageal reflux. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett'S-associated Dysplasia, Intramucosal Adenocarcinoma
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2013to Jan 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with either suspected or confirmed Barrett's-associated dysplasia or intramucosal adenocarcinoma presenting for endoscopy likely requiring EMR.
Who may be able to join
- Males and females over the age of 18 years.
- Patients with either suspected or confirmed Barrett's-associated dysplasia or intramucosal adenocarcinoma presenting for endoscopy likely requiring EMR.
- Only en-bloc resections will be investigated, requiring lesions with a maximum diameter of 15 mm with a Paris classification of 0-IIa, b, c, or a combination.
- Ability to provide written, informed consent.
- Women of childbearing potential must be willing to take a pregnancy test.
Who cannot join
- Patients on anticoagulation.
- Patients with esophageal varices that preclude either mucosal resection or biopsies.
- Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Catheter.
- Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Catheter.
- Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Catheter.
- Patients with known eosinophilic esophagitis.
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- Patients that are pregnant.
- Patients with a history of hemostasis disorders*.
- Patients with esophagitis above grade A.
- Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<100,000 plt/ul) and individuals with von Willibrand's disease or other known platelet malfunction disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Barrett's esophagus (BE) is a pre-neoplastic condition formed by the metaplasia of the normal squamous mucosa of the distal esophagus into a specialized intestinal mucosa. Its development is mostly associated with chronic injury from gastroesophageal reflux. BE is widely considered the leading risk factor for the development of esophageal adenocarcinoma (EAC).
Volumetric laser endomicroscopy (VLE) can be thought of as an analogous technique to ultrasound, however, instead of producing an image from the scattering of sound waves, it utilizes optical scattering based on differences in tissue composition to form a two-dimensional image. The benefit of VLE over ultrasound is that it is capable of generating cross-sectional images of tissues with an axial-resolution of up to 10 micrometers, which is comparable to low-power microscopy.
The proposed trial will evaluate the ability of physicians to use VLE to visualize high grade intraepithelial neoplasia (HGIN) or intramucosal adenocarcinoma (IMC) in both the ex-vivo and in-vivo setting and correlate those images to standard histology of endoscopic mucosal resection specimens as the gold standard.
Read the detailed description
The diagnosis of dysplasia and early adenocarcinoma in BE remains challenging. At present, endoscopy with biopsy of suspected BE lesions is the only available method. However, the endoscopic recognition of early dysplasia in BE relies on the subjective visual recognition by an endoscopist. The subtle mucosal variations and early dysplastic changes in the esophagus may easily be missed. The development of a wide-field, high resolution endoscopic microscopy could enhance the early detection and treatment of dysplasia in BE.
- Keywords
- Barrett's Esophagus, Dysplasia, Intramucosal Adenocarcinoma, EMR, Endoscopy
- Medical subject headings
- Barrett Esophagus
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation of features seen on VLE images to those seen on histopathology from mucosal resection specimens.
All VLE images will be evaluated by two independent reviewers (not the trial endoscopist performing the scan), who are blinded to the histological finding of the corresponding EMR specimen. A predefined classification scheme will be used for VLE assessment.
Measured: VLE images will be obtained during the day of the EGD (baseline). There is no follow-up period for this protocol. Correlation of features from VLE to histo will occur at the completion of enrollment.
Secondary outcomes (1)
The creation of an image atlas, to determine the intra- and inter-observer agreement on VLE images in correlation with histopathology, resulting in refinement of the existing VLE image interpretation criteria and the validation of the VLE classification.
All VLE images will be evaluated by two independent reviewers (not the trial endoscopist performing the scan), who are blinded to the histological finding of the corresponding EMR specimen.
Measured: VLE images will be obtained during the day of the EGD (baseline). There is no follow-up period for this protocol. The creation of the image atlas will occur at the completion of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2015
- Study completionJan 2015
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-associated DysplasiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NinePoint Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacques Bergman, MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862666
- Sponsor's protocol ID
- 12_01
- Status last verified
- Mar 2014
- First submitted
- 16 May 2013
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Swager AF, Tearney GJ, Leggett CL, van Oijen MGH, Meijer SL, Weusten BL, Curvers WL, Bergman JJGHM. Identification of volumetric laser endomicroscopy features predictive for early neoplasia in Barrett's esophagus using high-quality histological correlation. Gastrointest Endosc. 2017 May;85(5):918-926.e7. doi: 10.1016/j.gie.2016.09.012. Epub 2016 Sep 19.
PubMed 27658906
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Volumetric Laser Endomicroscopy (VLE) and Endoscopic Mucosal Resection (EMR) in Patients With Barrett's Dysplasia or Intramucosal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01862666
- Acronym / sponsor ID
- 12_01
- Keywords
- Barrett's Esophagus, Dysplasia, Intramucosal Adenocarcinoma, EMR, Endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NinePoint MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 May 2013 (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.
Barrett's esophagus (BE) is a pre-neoplastic condition formed by the metaplasia of the normal squamous mucosa of the distal esophagus into a specialized intestinal mucosa. Its development is mostly associated with chronic injury from gastroesophageal reflux. BE is widely considered the leading risk factor for the development of esophageal adenocarcinoma (EAC).
Volumetric laser endomicroscopy (VLE) can be thought of as an analogous technique to ultrasound, however, instead of producing an image from the scattering of sound waves, it utilizes optical scattering based on differences in tissue composition to form a two-dimensional image. The benefit of VLE over ultrasound is that it is capable of generating cross-sectional images of tissues with an axial-resolution of up to 10 micrometers, which is comparable to low-power microscopy.
The proposed trial will evaluate the ability of physicians to use VLE to visualize high grade intraepithelial neoplasia (HGIN) or intramucosal adenocarcinoma (IMC) in both the ex-vivo and in-vivo setting and correlate those images to standard histology of endoscopic mucosal resection specimens as the gold standard.
Detailed description
The diagnosis of dysplasia and early adenocarcinoma in BE remains challenging. At present, endoscopy with biopsy of suspected BE lesions is the only available method. However, the endoscopic recognition of early dysplasia in BE relies on the subjective visual recognition by an endoscopist. The subtle mucosal variations and early dysplastic changes in the esophagus may easily be missed. The development of a wide-field, high resolution endoscopic microscopy could enhance the early detection and treatment of dysplasia in BE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with either suspected or confirmed Barrett's-associated dysplasia or intramucosal adenocarcinoma presenting for endoscopy likely requiring EMR.
Key inclusion criteria (5 listed)
- Males and females over the age of 18 years.
- Patients with either suspected or confirmed Barrett's-associated dysplasia or intramucosal adenocarcinoma presenting for endoscopy likely requiring EMR.
- Ability to provide written, informed consent.
- Women of childbearing potential must be willing to take a pregnancy test.
Key exclusion criteria (10 listed)
- Patients on anticoagulation.
- Patients with esophageal varices that preclude either mucosal resection or biopsies.
- Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Catheter.
- Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Catheter.
- Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Catheter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation of features seen on VLE images to those seen on histopathology from mucosal resection specimens.
Time frame: VLE images will be obtained during the day of the EGD (baseline). There is no follow-up period for this protocol. Correlation of features from VLE to histo will occur at the completion of enrollment.
All VLE images will be evaluated by two independent reviewers (not the trial endoscopist performing the scan), who are blinded to the histological finding of the corresponding EMR specimen. A predefined classification scheme will be used for VLE assessment.
1 secondary outcome
The creation of an image atlas, to determine the intra- and inter-observer agreement on VLE images in correlation with histopathology, resulting in refinement of the existing VLE image interpretation criteria and the validation of the VLE classification.
Time frame: VLE images will be obtained during the day of the EGD (baseline). There is no follow-up period for this protocol. The creation of the image atlas will occur at the completion of enrollment.
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 19 Jun 2015.
- Derived from this study: PubMed 27658906Swager AF, Tearney GJ, Leggett CL, van Oijen MGH, Meijer SL, Weusten BL, Curvers WL, Bergman JJGHM. Identification of volumetric laser endomicroscopy features predictive for early neoplasia in Barrett's esophagus using high-quality histological correlation. Gastrointest Endosc. 2017 May;85(5):918-926.e7. doi: 10.1016/j.gie.2016.09.012. Epub 2016 Sep 19.
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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.
Jacques Bergman, MD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett'S-associated Dysplasia and Intramucosal Adenocarcinoma, run by NinePoint Medical at 1 site in Netherlands.
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 5 inclusion and 10 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 19 Jun 2015. 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 Netherlands. 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?
The correlation of features seen on VLE images to those seen on histopathology from mucosal resection specimens. (time frame: VLE images will be obtained during the day of the EGD (baseline). There is no follow-up period for this protocol. Correlation of features from VLE to histo will occur at the completion of enrollment.). 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 NCT01862666, 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 19 Jun 2015.