Polyp REcognition Assisted by a Device Interactive Characterization Tool - The PREDICT Study
Study Details
Study Description
Brief Summary
Diminutive colorectal polyps (≤ 5 mm) represent most of the polyps detected during colonoscopy, especially in the rectum-sigmoid tract. The characterization of these polyps by virtual chromoendoscopy is recognized as a key element for innovative imaging techniques. As a matter of facts diminutive colorectal polyps are very frequent and, if located in the rectosigmoid colon, they present a very low malignant risk (0.3% of evolution towards advanced adenoma and up to 0.08% of evolution towards invasive carcinoma). The real-time characterization would allow to identify the lowest risk polyps (hyperplastic subtype), to leave them in situ or, if resected, not to send them for histological examination, allowing a huge saving in healthcare associated costs.
Recently, the American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee established the Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document, specific for real-time histological assessment for tiny colorectal polyps, to establish reference quality thresholds. Two performance standards have been developed to guide the use of advanced imaging:
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for diminutive polyps to be resected and discarded without pathologic assessment, endoscopic technology (when used with high confidence) used to determine histology of polyps ≤ 5mm in size, when combined with the histopathology assessment of polyps > 5 mm in size, should provide a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps;
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in order for a technology to be used to guide the decision to leave suspected rectosigmoid hyperplastic polyps ≤ 5 mm in size in place (without resection), the technology should provide ≥ 90% negative predictive value (when used with high confidence) for adenomatous histology.
Computer-Aided-Diagnosis (CAD) is an artificial intelligence-based tool that would allow rapid and objective characterization of these lesions. The GI Genius CADx was developed to help endoscopists in their clinical practices for polyps characterization.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Interficial Intelligence Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available. |
Device: GI Genius CADe system
Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available.
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Outcome Measures
Primary Outcome Measures
- Negative Predictive Value of histology prediction on diminutive (≤5 mm) rectosigmoid polyps [1 day]
Secondary Outcome Measures
- Agreement in assignment of post-polypectomy surveillance intervals [1 day]
Agreement in assignment of post-polypectomy surveillance intervals according to established guidelines between: the assignment identified according to the combined GI Genius CADx histology prediction for diminutive (≤5 mm) polyps and histology for larger polyps (> 5 mm), and the assignment identified according to histology only.
Other Outcome Measures
- Sensitivity, Specificity, Accuracy, PPV and NPV of GI Genius CADx histology prediction and endoscopist assessment on all the identified lesions [1 day]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged 40-80 undergoing screening colonoscopy for CRC
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Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation.
Exclusion Criteria:
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subjects positive to Fecal Immunochemical Test or Fecal Occult Blood Test;
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subjects undergoing CRC surveillance colonoscopy
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subject at high risk for CRC
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subjects with a personal history of CRC, IBD or hereditary polyposic or non-polyposic syndromes;
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patients with previous resection of the sigmoid rectum;
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patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings;
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patients who perform an emergency colonoscopy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Endoscopy Unit, Humanitas Research Hospital | Rozzano | Milano | Italy | 20089 |
Sponsors and Collaborators
- Cosmo Artificial Intelligence-AI Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CB-17-08/05