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In the real-time pilot study, the performance of a recently developed Computer Aided Detection (CADe) system will be investigated in 30 patients during real-time live endoscopic examination. Three expert endoscopists in the field of Barrett's esophagus and endoscopic resection techniques will perform the inclusions following a standardized data acquisition protocol. In total, 15 patients with a visible neoplastic lesion in their Barrett's esophagus and 15 patients without any visible abnormalities in their Barrett's esophagus will be included in this study. Outcomes: to investigate feasibility of the use of the CADe system in the endoscopy suite, to investigate the performance of the CADe system when used by endoscopists.
Patients in this study will undergo a scheduled surveillance endoscopy (according to current guidelines; n = 15) or are referred to a tertiary referral center for endoscopic resection of a possible neoplastic area in their known Barrett's esophagus (n = 15).
Patients will be consciously sedated (standard care) before start of the procedure. During the endoscopic procedure, the endoscopist follows the standard protocol after extensive cleaning of the Barrett's segment: first, a standardized pullback video will be recorded, followed by a careful inspection of the Barrett segment every 2 centimeters. Per 2cm, a video of 10 seconds and 3 overview images are being recorded.
During the imaging protocol, the CADe system presents its prediction on a second screen, next to the main endoscopy monitor. After the imaging protocol, standard clinical care is being resumed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CADe system | All patients included in the study will undergo the endoscopic procedure according to standard clinical care and the study protocol. The CADe system will run in the back, not interfering with care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer Aided Detection system for Barrett's neoplasia | Other | CADe system running in the back, not directly interfering with patient care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined performance of endoscopist + CADe system in terms of per-patient sensitivity and specificity | To investigate the combined performance between endoscopist and CADe system on a per-patient level. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stand-alone performance of CADe system in terms of per-patient sensitivity and specificity | To investigate the performance of the CADe system on new data on a per-patient level. | 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with Barrett's esophagus, either receiving a surveillance endoscopy according to protocol or referred for endoscopic treatment for proven neoplasia in their Barrett's esophagus
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| Name | Affiliation | Role |
|---|---|---|
| J.J. Bergman, MD PHD | Amsterdam University Medical Centers, location AMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38604297 | Derived | Fockens KN, Jukema JB, Jong MR, Boers T, van der Putten JA, Kusters CHJ, Pouw RE, Duits LC, van der Sommen F, de With PH, de Groof AJ, Bergman JJ; BONS-AI consortium. The use of a real-time computer-aided detection system for visible lesions in the Barrett's esophagus during live endoscopic procedures: a pilot study (with video). Gastrointest Endosc. 2024 Sep;100(3):527-531.e3. doi: 10.1016/j.gie.2024.04.011. Epub 2024 Apr 9. |
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Individual participant data will not be shared
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D004066 |
| Digestive System Diseases |