Barrett EsophagusNCT04621474
Non-magnified NBI in Barrett's Oesophagus Neoplasia Detection and Delineation
An observational study of Barrett Esophagus, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
Endoscopy plays a pivotal role in the management (diagnosis and treatment) of Barrett's related neoplasia. The standard endoscopy is generally done under white light, which is known to be imperfect in detecting early neoplastic lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Narrow band imaging (NBI)
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2019to 8 Apr 2021
- 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 undergoing surveillance for Barrett's oesophagus or work up for Barrett's related neoplasia
Who may be able to join
- Diagnosed with dysplastic or non-dysplastic BO at least C1 or M2 in length
Who cannot join
- Reflux oesophagitis (Los Angeles grade ≥C);
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
MRC Cancer Unit
Cambridge, CB2 0XZ
Massimiliano di Pietro, MD, 01223763349, md460@mrc-cu.cam.ac.uk
About this study
Official title: The Utility of Non-magnified NBI in Barrett's Oesophagus Neoplasia Detection and Delineation by Non-expert Endoscopists
Endoscopy plays a pivotal role in the management (diagnosis and treatment) of Barrett's related neoplasia. The standard endoscopy is generally done under white light, which is known to be imperfect in detecting early neoplastic lesion. Narrow band imaging (NBI) improves definition of the superficial morphology and vasculature of GI mucosa. Some studies have shown the potential to improve diagnostic accuracy and reduce the number of biopsies required for Barrett's related neoplasia. This can ultimately improve the cost-effectiveness of endoscopic surveillance. The ability to discriminate between healthy and diseased tissue also makes NBI a useful technique for the delineation of lesions to treat with endoscopic mucosal resection (EMR). However not all studies provide evidence of diagnostic utility. Also the majority of these studies have been conducted by expert endoscopists, which makes the results difficult to extend to general endoscopy practice. The limited number of Barrett's specialists in certain areas of the country validates the need for a study to investigate whether there is an objective improvement in detection and delineation of Barrett's neoplastic lesions by less experienced observers. The aim of this study was to determine the utility of non-magnified NBI in non-expert identification of lesions as compared to expert endoscopists as well as the inter-observer agreement among endoscopists on WLE and NBI.
Read the detailed description
Matched non-magnified white-light endoscopy (WLE) and narrow band imaging (NBI) images of Barrett's oesophagus with and without lesions from the same level will be obtained prospectively. Lesions will be delineated by 3 expert endoscopists and the overlap between all delineations for each image, regarded as the "sweet spot", will be used as the gold standard. The images will then be assessed by a group of non-expert endoscopists (trainees and nurse endoscopists) as well as senior endoscopists with no interest in Barrett's. First, white light images will be assessed, followed by a wash-out period and then NBI. Assessments will be carried out using a computer application designed in MATLAB. Observers will be also asked to complete the following 1) Paris classification of lesion 2) delineation of the lesion on the screen 3) rate the ability to delineate the lesion for each of the two respective imaging modalities (using a Visual analog scale (VAS score 1-10), 4) choice a single point for virtual diagnostic biopsy. Thus, the quantitative interobserver agreement of the delineations for WLE and NBI will be calculated. VAS scores for the ability to delineate the lesion will be compared between WLE and NBI. Rate of inclusion of the biopsy point in the sweet spot on WLE and NBI will be compared.
- Conditions
- Barrett Esophagus
- Being tested
- Narrow band imaging (NBI)
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow band imaging (NBI)Diagnostic test
Also called Non-magnified white-light endoscopy (WLE)
Narrow-band imaging uses specific light wavelengths of 415 nm (blue) and 540 nm (green) due to a special filter which is electronically activated by a switch in the endoscope.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion identification
Identification of lesions by non Barrett's expert endoscopists on WLE and non-magnified NBI as compared to expert endoscopists
Measured: 1 year
Inter-observer agreement
Inter-observer agreement among endoscopists on WLE and NBI
Measured: 1 year
Secondary outcomes (1)
Preferred imaging modality
Preferred imaging modality for assessment of Barrett's by endoscopists
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 posted9 Nov 2020
- Study start8 Apr 2019
- Primary completion8 Apr 2021 (estimated)
- Study completion8 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Barrett EsophagusStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimiliano di Pietro, MD, University of Cambridge
- Investigators
- Massimiliano di Pietro, MD, Principal investigator, MRC Cancer Unit.University of Cambridge.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621474
- Sponsor's protocol ID
- NiBOD
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sami SS, Subramanian V, Butt WM, Bejkar G, Coleman J, Mannath J, Ragunath K. High definition versus standard definition white light endoscopy for detecting dysplasia in patients with Barrett's esophagus. Dis Esophagus. 2015 Nov-Dec;28(8):742-9. doi: 10.1111/dote.12283. Epub 2014 Sep 10.
PubMed 25209721Swager AF, Curvers WL, Bergman JJ. Diagnosis by Endoscopy and Advanced Imaging of Barrett's Neoplasia. Adv Exp Med Biol. 2016;908:81-98. doi: 10.1007/978-3-319-41388-4_5.
PubMed 27573768Sharma P, Hawes RH, Bansal A, Gupta N, Curvers W, Rastogi A, Singh M, Hall M, Mathur SC, Wani SB, Hoffman B, Gaddam S, Fockens P, Bergman JJ. Standard endoscopy with random biopsies versus narrow band imaging targeted biopsies in Barrett's oesophagus: a prospective, international, randomised controlled trial. Gut. 2013 Jan;62(1):15-21. doi: 10.1136/gutjnl-2011-300962. Epub 2012 Feb 7.
PubMed 22315471Yoshida T, Inoue H, Usui S, Satodate H, Fukami N, Kudo SE. Narrow-band imaging system with magnifying endoscopy for superficial esophageal lesions. Gastrointest Endosc. 2004 Feb;59(2):288-95. doi: 10.1016/s0016-5107(03)02532-x.
PubMed 14745410de Groof AJ, Swager AF, Pouw RE, Weusten BLAM, Schoon EJ, Bisschops R, Pech O, Meining A, Neuhaus H, Curvers WL, Bergman JJGHM. Blue-light imaging has an additional value to white-light endoscopy in visualization of early Barrett's neoplasia: an international multicenter cohort study. Gastrointest Endosc. 2019 Apr;89(4):749-758. doi: 10.1016/j.gie.2018.10.046. Epub 2018 Nov 9.
PubMed 30419218
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Non-magnified NBI in Barrett's Oesophagus Neoplasia Detection and Delineation by Non-expert Endoscopists
- ClinicalTrials.gov ID
- NCT04621474
- Acronym / sponsor ID
- NiBOD
- Conditions
- Barrett Esophagus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 8 Apr 2021 (estimated)
- Study completion
- 8 Apr 2021 (estimated)
- First posted
- 9 Nov 2020 (actual)
- 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.
Endoscopy plays a pivotal role in the management (diagnosis and treatment) of Barrett's related neoplasia. The standard endoscopy is generally done under white light, which is known to be imperfect in detecting early neoplastic lesion. Narrow band imaging (NBI) improves definition of the superficial morphology and vasculature of GI mucosa. Some studies have shown the potential to improve diagnostic accuracy and reduce the number of biopsies required for Barrett's related neoplasia. This can ultimately improve the cost-effectiveness of endoscopic surveillance. The ability to discriminate between healthy and diseased tissue also makes NBI a useful technique for the delineation of lesions to treat with endoscopic mucosal resection (EMR). However not all studies provide evidence of diagnostic utility. Also the majority of these studies have been conducted by expert endoscopists, which makes the results difficult to extend to general endoscopy practice. The limited number of Barrett's specialists in certain areas of the country validates the need for a study to investigate whether there is an objective improvement in detection and delineation of Barrett's neoplastic lesions by less experienced observers. The aim of this study was to determine the utility of non-magnified NBI in non-expert identification of lesions as compared to expert endoscopists as well as the inter-observer agreement among endoscopists on WLE and NBI.
Detailed description
Matched non-magnified white-light endoscopy (WLE) and narrow band imaging (NBI) images of Barrett's oesophagus with and without lesions from the same level will be obtained prospectively. Lesions will be delineated by 3 expert endoscopists and the overlap between all delineations for each image, regarded as the "sweet spot", will be used as the gold standard. The images will then be assessed by a group of non-expert endoscopists (trainees and nurse endoscopists) as well as senior endoscopists with no interest in Barrett's. First, white light images will be assessed, followed by a wash-out period and then NBI. Assessments will be carried out using a computer application designed in MATLAB. Observers will be also asked to complete the following 1) Paris classification of lesion 2) delineation of the lesion on the screen 3) rate the ability to delineate the lesion for each of the two respective imaging modalities (using a Visual analog scale (VAS score 1-10), 4) choice a single point for virtual diagnostic biopsy. Thus, the quantitative interobserver agreement of the delineations for WLE and NBI will be calculated. VAS scores for the ability to delineate the lesion will be compared between WLE and NBI. Rate of inclusion of the biopsy point in the sweet spot on WLE and NBI will be compared.
Study design
- Observational model
- Case only
- 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 undergoing surveillance for Barrett's oesophagus or work up for Barrett's related neoplasia
Key inclusion criteria (1 listed)
- Diagnosed with dysplastic or non-dysplastic BO at least C1 or M2 in length
Key exclusion criteria (1 listed)
- Reflux oesophagitis (Los Angeles grade ≥C);
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 |
|---|---|---|
| Narrow band imaging (NBI)Also: Non-magnified white-light endoscopy (WLE)Narrow-band imaging uses specific light wavelengths of 415 nm (blue) and 540 nm (green) due to a special filter which is electronically activated by a switch in the endoscope. | Diagnostic test | – |
Primary outcome
Lesion identification
Time frame: 1 year
Identification of lesions by non Barrett's expert endoscopists on WLE and non-magnified NBI as compared to expert endoscopists
Inter-observer agreement
Time frame: 1 year
Inter-observer agreement among endoscopists on WLE and NBI
1 secondary outcome
Preferred imaging modality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Background: PubMed 25209721Sami SS, Subramanian V, Butt WM, Bejkar G, Coleman J, Mannath J, Ragunath K. High definition versus standard definition white light endoscopy for detecting dysplasia in patients with Barrett's esophagus. Dis Esophagus. 2015 Nov-Dec;28(8):742-9. doi: 10.1111/dote.12283. Epub 2014 Sep 10.
- Background: PubMed 27573768Swager AF, Curvers WL, Bergman JJ. Diagnosis by Endoscopy and Advanced Imaging of Barrett's Neoplasia. Adv Exp Med Biol. 2016;908:81-98. doi: 10.1007/978-3-319-41388-4_5.
- Results publication: PubMed 22315471Sharma P, Hawes RH, Bansal A, Gupta N, Curvers W, Rastogi A, Singh M, Hall M, Mathur SC, Wani SB, Hoffman B, Gaddam S, Fockens P, Bergman JJ. Standard endoscopy with random biopsies versus narrow band imaging targeted biopsies in Barrett's oesophagus: a prospective, international, randomised controlled trial. Gut. 2013 Jan;62(1):15-21. doi: 10.1136/gutjnl-2011-300962. Epub 2012 Feb 7.
- Results publication: PubMed 14745410Yoshida T, Inoue H, Usui S, Satodate H, Fukami N, Kudo SE. Narrow-band imaging system with magnifying endoscopy for superficial esophageal lesions. Gastrointest Endosc. 2004 Feb;59(2):288-95. doi: 10.1016/s0016-5107(03)02532-x.
- Results publication: PubMed 30419218de Groof AJ, Swager AF, Pouw RE, Weusten BLAM, Schoon EJ, Bisschops R, Pech O, Meining A, Neuhaus H, Curvers WL, Bergman JJGHM. Blue-light imaging has an additional value to white-light endoscopy in visualization of early Barrett's neoplasia: an international multicenter cohort study. Gastrointest Endosc. 2019 Apr;89(4):749-758. doi: 10.1016/j.gie.2018.10.046. Epub 2018 Nov 9.
- Individual participant dataSharing planned: No
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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.
Massimiliano di Pietro, MD principal investigator
MRC Cancer Unit.University of Cambridge.
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 Esophagus, run by University of Cambridge at 1 site in United Kingdom.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Nov 2020. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimiliano di Pietro, MD (01223763349, md460@mrc-cu.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion identification (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT04621474, which also lists 5 linked publications.
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 9 Nov 2020.