Narrow Band Imaging Project on Barrett's Esophagus
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Purpose
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.
| Condition |
|---|
|
Barrett's Esophagus Gastroesophageal Reflux Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Assessment of a Consensus Driven Narrow Band Imaging (NBI) Pattern Classification System in Barrett's Esophagus (BE) |
- Determine the inter-observer agreement of a consensus driven NBI classification system in Barrett's esophagus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Accuracy of the NBI patterns in predicting dysplasia in Barrett's esophagus based on confidence and image quality. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Accuracy of the newer patterns for diagnosing dysplasia in Barrett's esophagus based on confidence and image quality perceived by the reviewer.
- Sensitivity of the newer NBI classification in identifying dysplasia in Barrett's esophagus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Sensitivity of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
- Specificity of the newer NBI classification in identifying dysplasia in Barrett's esophagus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Specificity of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
- Positive predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Positive predictive value of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
- Negative predictive value of the newer NBI classification in identifying dysplasia in Barrett's esophagus. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Negative predictive value of the newer NBI patterns in predicting dysplasia in Barrett's esophagus.
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
BE with dysplasia.
Patients having Barrett's esophagus with dysplasia.
|
|
BE without dysplasia.
Patients having Barrett's esophagus without dysplasia.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Contacts and Locations| Contact: April Higbee, RN,BSN | 816-861-4700 ext 57456 | april.higbee@va.gov |
| United States, Illinois | |
| The University of Chicago Medical Center | Not yet recruiting |
| Chicago, Illinois, United States | |
| Contact: Irving Waxman, MD | |
| Principal Investigator: Irving Waxman, MD | |
| United States, Missouri | |
| Kansas City VA Medical Center | Not yet recruiting |
| Kansas City, Missouri, United States, 64128 | |
| Contact: April Higbee, RN,BSN 816-861-4700 ext 57456 april.higbee@va.gov | |
| Principal Investigator: Prateek Sharma, MD | |
| Germany | |
| University of Regensburg | Not yet recruiting |
| Augsburg, Germany | |
| Contact: Helmut Messman, MD | |
| Principal Investigator: Helmut Messman, MD | |
| Netherlands | |
| Amsterdam Medical Center | Not yet recruiting |
| Amsterdam, Netherlands | |
| Contact: Jacques Bergman | |
| Principal Investigator: Jacques Bergman, MD | |
| Principal Investigator: | Prateek Sharma, MD | Kansas City VA Medical Center |
| Principal Investigator: | Irving Waxman, MD | University of Chicago |
| Principal Investigator: | Jacques Bergman, MD, PhD | Amsterdam Medical Center |
| Principal Investigator: | Helmut Messman, MD | University of Regensburg |
| Principal Investigator: | Kenichi Goda, MD | Jikei University |
| Principal Investigator: | Motosugu Kato, MD | Hokkaido University |
More Information
Publications:
| Responsible Party: | PRATEEK SHARMA, Principal Investigator, Midwest Biomedical Research Foundation |
| ClinicalTrials.gov Identifier: | NCT01580631 History of Changes |
| Other Study ID Numbers: | PS0059 |
| Study First Received: | April 4, 2012 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Midwest Biomedical Research Foundation:
|
Narrow band imaging Barrett's esophagus Gastroesophageal reflux disease |
Additional relevant MeSH terms:
|
Barrett Esophagus Gastroesophageal Reflux Digestive System Abnormalities Digestive System Diseases |
Esophageal Diseases Gastrointestinal Diseases Esophageal Motility Disorders Deglutition Disorders |
ClinicalTrials.gov processed this record on June 18, 2013