Barrett's EsophagusNCT01580631
Narrow Band Imaging Project on Barrett's Esophagus
An observational study of Barrett's Esophagus and Gastroesophageal Reflux Disease, run by Midwest Biomedical Research at 4 sites in 3 countries.
Trial summary
Narrow Band Imaging(NBI) improves image contrast by allowing the blue light centered at 415 nanometers which is heavily absorbed by oxyhemoglobin to highlight the tissue's microvasculature and enhances detail on the surface of the mucosa revealing subtle changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus, Gastroesophageal Reflux Disease
- How many people
- 50 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Oct 2012to Dec 2025
- 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: Eligible subjects at the participating institution who meet the inclusion criteria for this study will be offered the opportunity to participate in this clinical trial.
Who may be able to join
- Patients age: ≥ 18 years
- Undergoing endoscopy for surveillance or endoscopic treatment of Barrett's esophagus
- Ability to take oral proton pump inhibitor
- For female subjects of childbearing potential, a negative urine pregnancy test within 2 weeks of enrollment and any subsequent endoscopy encounter
- Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the investigational plan
- Ability to discontinue Aspirin/NSAIDs/Clopidogrel 7 days before and after all ablation procedures
- Ability to provide written, informed consent and understands the responsibilities of trial participation
Who cannot join
- The subject is pregnant or planning a pregnancy during the study period (12 months after treatment)
- Esophageal stricture preventing passage of endoscope or catheter
- Active erosive esophagitis
- Prior endoscopic therapy with endoscopic mucosal resection, radiofrequency ablation, etc.
- History of esophageal varices or coagulopathy
- Prior radiation therapy to the esophagus, except head and neck region radiation therapy.
Show all 10Show fewer
- Evidence of esophageal varices during treatment endoscopy
- Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
- The subject is currently enrolled in an investigational drug or device trial that clinically interferes with the current study.
- Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
The University of Chicago Medical Center
Chicago, Illinois
Kansas City VA Medical Center
Kansas City, Missouri, 64128
About this study
Official title: Assessment of a Consensus Driven Narrow Band Imaging (NBI) Pattern Classification System in Barrett's Esophagus (BE)
Narrow Band Imaging(NBI) improves image contrast by allowing the blue light centered at 415 nanometers which is heavily absorbed by oxyhemoglobin to highlight the tissue's microvasculature and enhances detail on the surface of the mucosa revealing subtle changes. Barrett's esophagus(BE) has the mucosal and vessel changes during cancer transformation by angiogenesis. The ability of the NBI scope to visualize submucosal vessels forms the premise for the prediction of dysplasia in BE mucosa.
NBI images of the BE mucosa obtained during endoscopy will be classified by academic endoscopists and community endoscopists initially. The endoscopists will then be asked to predict histopathology based on the NBI surface patterns. This clinical trial will evaluate the inter-observer agreement of a simple, consensus driven narrow band imaging (NBI) classification system of surface patterns and its ability to differentiate dysplastic versus non-dysplastic Barrett's esophagus(BE) in patients undergoing BE screening or surveillance in expert academic centers and in community GI practice as well. Their performance will be evaluated for accuracy, sensitivity, specificity, positive predictive value and negative predictive value of each pattern that is visualized on NBI.
Read the detailed description
This is a multicenter, prospective, double-blinded study of NBI images from 50 patients enrolled in the study. Patients undergoing BE screening and BE surveillance will be enrolled into the study. After meeting eligibility criteria, and obtaining an informed consent, patients will undergo their routine upper endoscopic examination using white light endoscopy. During the course of the upper endoscopy, the BE surface patterns will be carefully examined with the endoscope in overview mode (with the endoscope in the center of the esophageal lumen) and then in close proximity to the BE surface (approximately 3-5 mm away from the mucosa). In each of these positions, a maximum of 4 high quality images will be obtained from different surface patterns initially with WLE and then using NBI. Image capture will be standardized. All the images will be classified based upon a simplified NBI classification system using two main criteria:(1)mucosal pattern(regular/irregular/uncertain) and (2)vascular pattern (regular/irregular/uncertain). All images will be captured using a high-definition, NBI endoscope (190 endoscopes-GIF-HQ 190 [dual focus],Olympus Inc) and stored in the high quality TIFF format. After images have been obtained, target biopsies will be obtained from each area and submitted for histopathological evaluation in separate jars. From the reports on NBI patterns from the images by Gastroenterologist and corresponding histopathological details, the accuracy and interobserver agreement of this NBI classification system will be determined.
- Keywords
- Narrow band imaging, Barrett's esophagus, Gastroesophageal reflux disease
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BE with dysplasia. | Patients having Barrett's esophagus with dysplasia. | |
| BE without dysplasia. | Patients having Barrett's esophagus without dysplasia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the inter-observer agreement of a consensus driven NBI classification system in Barrett's esophagus.
Identifying newer consensus driven NBI classification system in Barrett's esophagus for better inter observer agreement among experts and community/general gastroenterologists. Higher interobserver agreement (measured by Landis and Koch method) on these NBI patterns in Barrett's esophagus will help in diagnosing dysplasia in an uniform way among the gastroenterologists.
Measured: 12 months
Secondary outcomes (5)
Accuracy of the NBI patterns in predicting dysplasia in Barrett's esophagus based on confidence and image quality.
Accuracy of the newer patterns for diagnosing dysplasia in Barrett's esophagus based on confidence and image quality perceived by the reviewer.
Measured: 12 months
Sensitivity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Sensitivity of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
Measured: 12 months
Specificity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Specificity of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
Measured: 12 months
Positive predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Positive predictive value of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
Measured: 12 months
Negative predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Negative predictive value of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Barrett's 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwest Biomedical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas City Veteran Affairs Medical Center
- Responsible party
- Principal investigator, PRATEEK SHARMA, Midwest Biomedical Research
- Investigators
- Prateek Sharma, MD, Principal investigator, Kansas City VA Medical CenterIrving Waxman, MD, Principal investigator, University of ChicagoJacques Bergman, MD, PhD, Principal investigator, Amsterdam UMC, location VUmcHelmut Messman, MD, Principal investigator, University of RegensburgKenichi Goda, MD, Principal investigator, Jikei UniversityMotosugu Kato, MD, Principal investigator, Hokkaido University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580631
- Sponsor's protocol ID
- PS0059
- Status last verified
- Mar 2023
- First submitted
- 4 Apr 2012
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Reid BJ, Sanchez CA, Blount PL, Levine DS. Barrett's esophagus: cell cycle abnormalities in advancing stages of neoplastic progression. Gastroenterology. 1993 Jul;105(1):119-29. doi: 10.1016/0016-5085(93)90017-7.
PubMed 8514029Wang KK, Sampliner RE; Practice Parameters Committee of the American College of Gastroenterology. Updated guidelines 2008 for the diagnosis, surveillance and therapy of Barrett's esophagus. Am J Gastroenterol. 2008 Mar;103(3):788-97. doi: 10.1111/j.1572-0241.2008.01835.x. No abstract available.
PubMed 18341497Sharma P, McQuaid K, Dent J, Fennerty MB, Sampliner R, Spechler S, Cameron A, Corley D, Falk G, Goldblum J, Hunter J, Jankowski J, Lundell L, Reid B, Shaheen NJ, Sonnenberg A, Wang K, Weinstein W; AGA Chicago Workshop. A critical review of the diagnosis and management of Barrett's esophagus: the AGA Chicago Workshop. Gastroenterology. 2004 Jul;127(1):310-30. doi: 10.1053/j.gastro.2004.04.010.
PubMed 15236196Cooper GS, Kou TD, Chak A. Receipt of previous diagnoses and endoscopy and outcome from esophageal adenocarcinoma: a population-based study with temporal trends. Am J Gastroenterol. 2009 Jun;104(6):1356-62. doi: 10.1038/ajg.2009.159. Epub 2009 May 12.
PubMed 19491849Corley DA, Levin TR, Habel LA, Weiss NS, Buffler PA. Surveillance and survival in Barrett's adenocarcinomas: a population-based study. Gastroenterology. 2002 Mar;122(3):633-40. doi: 10.1053/gast.2002.31879.
PubMed 11874995Sharma P, Falk GW, Weston AP, Reker D, Johnston M, Sampliner RE. Dysplasia and cancer in a large multicenter cohort of patients with Barrett's esophagus. Clin Gastroenterol Hepatol. 2006 May;4(5):566-72. doi: 10.1016/j.cgh.2006.03.001. Epub 2006 Apr 17.
PubMed 16630761Inadomi JM, Sampliner R, Lagergren J, Lieberman D, Fendrick AM, Vakil N. Screening and surveillance for Barrett esophagus in high-risk groups: a cost-utility analysis. Ann Intern Med. 2003 Feb 4;138(3):176-86. doi: 10.7326/0003-4819-138-3-200302040-00009.
PubMed 12558356Inadomi JM. Surveillance in Barrett's esophagus: a failed premise. Keio J Med. 2009 Mar;58(1):12-8. doi: 10.2302/kjm.58.12.
PubMed 19398879Falk GW, Rice TW, Goldblum JR, Richter JE. Jumbo biopsy forceps protocol still misses unsuspected cancer in Barrett's esophagus with high-grade dysplasia. Gastrointest Endosc. 1999 Feb;49(2):170-6. doi: 10.1016/s0016-5107(99)70482-7.
PubMed 9925694Reid BJ, Blount PL, Feng Z, Levine DS. Optimizing endoscopic biopsy detection of early cancers in Barrett's high-grade dysplasia. Am J Gastroenterol. 2000 Nov;95(11):3089-96. doi: 10.1111/j.1572-0241.2000.03182.x.
PubMed 11095322Egger K, Werner M, Meining A, Ott R, Allescher HD, Hofler H, Classen M, Rosch T. Biopsy surveillance is still necessary in patients with Barrett's oesophagus despite new endoscopic imaging techniques. Gut. 2003 Jan;52(1):18-23. doi: 10.1136/gut.52.1.18.
PubMed 12477753
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Consensus Driven Narrow Band Imaging (NBI) Pattern Classification System in Barrett's Esophagus (BE)
- ClinicalTrials.gov ID
- NCT01580631
- Acronym / sponsor ID
- PS0059
- Keywords
- Narrow band imaging, Barrett's esophagus, Gastroesophageal reflux disease
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Midwest Biomedical ResearchUniversity, hospital or other
- Collaborators
- Kansas City Veteran Affairs Medical Center
- Study start
- Oct 2012
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Apr 2012 (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.
Narrow Band Imaging(NBI) improves image contrast by allowing the blue light centered at 415 nanometers which is heavily absorbed by oxyhemoglobin to highlight the tissue's microvasculature and enhances detail on the surface of the mucosa revealing subtle changes. Barrett's esophagus(BE) has the mucosal and vessel changes during cancer transformation by angiogenesis. The ability of the NBI scope to visualize submucosal vessels forms the premise for the prediction of dysplasia in BE mucosa.
NBI images of the BE mucosa obtained during endoscopy will be classified by academic endoscopists and community endoscopists initially. The endoscopists will then be asked to predict histopathology based on the NBI surface patterns. This clinical trial will evaluate the inter-observer agreement of a simple, consensus driven narrow band imaging (NBI) classification system of surface patterns and its ability to differentiate dysplastic versus non-dysplastic Barrett's esophagus(BE) in patients undergoing BE screening or surveillance in expert academic centers and in community GI practice as well. Their performance will be evaluated for accuracy, sensitivity, specificity, positive predictive value and negative predictive value of each pattern that is visualized on NBI.
Detailed description
This is a multicenter, prospective, double-blinded study of NBI images from 50 patients enrolled in the study. Patients undergoing BE screening and BE surveillance will be enrolled into the study. After meeting eligibility criteria, and obtaining an informed consent, patients will undergo their routine upper endoscopic examination using white light endoscopy. During the course of the upper endoscopy, the BE surface patterns will be carefully examined with the endoscope in overview mode (with the endoscope in the center of the esophageal lumen) and then in close proximity to the BE surface (approximately 3-5 mm away from the mucosa). In each of these positions, a maximum of 4 high quality images will be obtained from different surface patterns initially with WLE and then using NBI. Image capture will be standardized. All the images will be classified based upon a simplified NBI classification system using two main criteria:(1)mucosal pattern(regular/irregular/uncertain) and (2)vascular pattern (regular/irregular/uncertain). All images will be captured using a high-definition, NBI endoscope (190 endoscopes-GIF-HQ 190 [dual focus],Olympus Inc) and stored in the high quality TIFF format. After images have been obtained, target biopsies will be obtained from each area and submitted for histopathological evaluation in separate jars. From the reports on NBI patterns from the images by Gastroenterologist and corresponding histopathological details, the accuracy and interobserver agreement of this NBI classification system will be determined.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BE with dysplasia. | – | –Patients having Barrett's esophagus with dysplasia. |
| BE without dysplasia. | – | –Patients having Barrett's esophagus without dysplasia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects at the participating institution who meet the inclusion criteria for this study will be offered the opportunity to participate in this clinical trial.
Key inclusion criteria (7 listed)
- Patients age: ≥ 18 years
- Undergoing endoscopy for surveillance or endoscopic treatment of Barrett's esophagus
- Ability to take oral proton pump inhibitor
- For female subjects of childbearing potential, a negative urine pregnancy test within 2 weeks of enrollment and any subsequent endoscopy encounter
- Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the investigational plan
Key exclusion criteria (10 listed)
- The subject is pregnant or planning a pregnancy during the study period (12 months after treatment)
- Esophageal stricture preventing passage of endoscope or catheter
- Active erosive esophagitis
- Prior endoscopic therapy with endoscopic mucosal resection, radiofrequency ablation, etc.
- History of esophageal varices or coagulopathy
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
Determine the inter-observer agreement of a consensus driven NBI classification system in Barrett's esophagus.
Time frame: 12 months
Identifying newer consensus driven NBI classification system in Barrett's esophagus for better inter observer agreement among experts and community/general gastroenterologists. Higher interobserver agreement (measured by Landis and Koch method) on these NBI patterns in Barrett's esophagus will help in diagnosing dysplasia in an uniform way among the gastroenterologists.
5 secondary outcomes
Accuracy of the NBI patterns in predicting dysplasia in Barrett's esophagus based on confidence and image quality.
Time frame: 12 months
Sensitivity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Time frame: 12 months
Specificity of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Time frame: 12 months
Positive predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Time frame: 12 months
Negative predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 8514029Reid BJ, Sanchez CA, Blount PL, Levine DS. Barrett's esophagus: cell cycle abnormalities in advancing stages of neoplastic progression. Gastroenterology. 1993 Jul;105(1):119-29. doi: 10.1016/0016-5085(93)90017-7.
- Background: PubMed 18341497Wang KK, Sampliner RE; Practice Parameters Committee of the American College of Gastroenterology. Updated guidelines 2008 for the diagnosis, surveillance and therapy of Barrett's esophagus. Am J Gastroenterol. 2008 Mar;103(3):788-97. doi: 10.1111/j.1572-0241.2008.01835.x. No abstract available.
- Background: PubMed 15236196Sharma P, McQuaid K, Dent J, Fennerty MB, Sampliner R, Spechler S, Cameron A, Corley D, Falk G, Goldblum J, Hunter J, Jankowski J, Lundell L, Reid B, Shaheen NJ, Sonnenberg A, Wang K, Weinstein W; AGA Chicago Workshop. A critical review of the diagnosis and management of Barrett's esophagus: the AGA Chicago Workshop. Gastroenterology. 2004 Jul;127(1):310-30. doi: 10.1053/j.gastro.2004.04.010.
- Background: PubMed 19491849Cooper GS, Kou TD, Chak A. Receipt of previous diagnoses and endoscopy and outcome from esophageal adenocarcinoma: a population-based study with temporal trends. Am J Gastroenterol. 2009 Jun;104(6):1356-62. doi: 10.1038/ajg.2009.159. Epub 2009 May 12.
- Background: PubMed 11874995Corley DA, Levin TR, Habel LA, Weiss NS, Buffler PA. Surveillance and survival in Barrett's adenocarcinomas: a population-based study. Gastroenterology. 2002 Mar;122(3):633-40. doi: 10.1053/gast.2002.31879.
- Background: PubMed 16630761Sharma P, Falk GW, Weston AP, Reker D, Johnston M, Sampliner RE. Dysplasia and cancer in a large multicenter cohort of patients with Barrett's esophagus. Clin Gastroenterol Hepatol. 2006 May;4(5):566-72. doi: 10.1016/j.cgh.2006.03.001. Epub 2006 Apr 17.
- Background: PubMed 12558356Inadomi JM, Sampliner R, Lagergren J, Lieberman D, Fendrick AM, Vakil N. Screening and surveillance for Barrett esophagus in high-risk groups: a cost-utility analysis. Ann Intern Med. 2003 Feb 4;138(3):176-86. doi: 10.7326/0003-4819-138-3-200302040-00009.
- Background: PubMed 19398879Inadomi JM. Surveillance in Barrett's esophagus: a failed premise. Keio J Med. 2009 Mar;58(1):12-8. doi: 10.2302/kjm.58.12.
- Background: PubMed 9925694Falk GW, Rice TW, Goldblum JR, Richter JE. Jumbo biopsy forceps protocol still misses unsuspected cancer in Barrett's esophagus with high-grade dysplasia. Gastrointest Endosc. 1999 Feb;49(2):170-6. doi: 10.1016/s0016-5107(99)70482-7.
- Background: PubMed 11095322Reid BJ, Blount PL, Feng Z, Levine DS. Optimizing endoscopic biopsy detection of early cancers in Barrett's high-grade dysplasia. Am J Gastroenterol. 2000 Nov;95(11):3089-96. doi: 10.1111/j.1572-0241.2000.03182.x.
- Background: PubMed 12477753Egger K, Werner M, Meining A, Ott R, Allescher HD, Hofler H, Classen M, Rosch T. Biopsy surveillance is still necessary in patients with Barrett's oesophagus despite new endoscopic imaging techniques. Gut. 2003 Jan;52(1):18-23. doi: 10.1136/gut.52.1.18.
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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.
Prateek Sharma, MD principal investigator
Kansas City VA Medical Center
Irving Waxman, MD principal investigator
University of Chicago
Jacques Bergman, MD, PhD principal investigator
Amsterdam UMC, location VUmc
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus and Gastroesophageal Reflux Disease, run by Midwest Biomedical Research at 4 sites in 3 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 7 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: paused, as of the sponsor's last update on 16 Mar 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, 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?
Results are not available in the source record.
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?
Determine the inter-observer agreement of a consensus driven NBI classification system in Barrett's esophagus. (time frame: 12 months). 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 NCT01580631, which also lists 11 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 16 Mar 2023.