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We aim to investigate the incremental detection rate of polyps using AI- assisted colonoscopy compared with high-definition white-light endoscopy (HD-WLE).
We will conduct a single-center randomized tandem colonoscopy trial of patients with Lynch syndrome with and without AI. Patients will undergo tandem colonoscopy, the second colonoscopy with either HD-WLE or an AI- assisted device.
We will include patients with a known pathogenic variant (PV) / likely PV in one of the MMR genes, who are undergoing endoscopic screening and surveillance in our institute. Patients will undergo a first colonoscopy with HD-WLE, and will be randomized at 1:1 ratio to undergo a second colonoscopy with either HD-WLE or an AI- assisted device. All visualized polyps will be removed and size, histology and numbers of polyps detected on each exam will be recorded. We will evaluate the adenoma detection rate and polyp detection rate in each arm and the number of adenomas / polyps in each arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high-definition white-light endoscopy | No Intervention | patients undergoing first and second colonoscopy with high-definition white-light endoscopy | |
| artificial intelligence | Active Comparator | patients undergoing first colonoscopy with high-definition white-light endoscopy and second colonoscopy with artificial intelligence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| artificial intelligence | Diagnostic Test | patients will undergo tandem colonoscopy with artificial intelligence |
|
| Measure | Description | Time Frame |
|---|---|---|
| adenoma incremental detection rate | per lesion analysis, the incremental detection rate will be calculated, defined as the number of lesions detected during the second colonoscopy divided by the total number of lesions detected during first and second colonoscopy combined. | From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).] |
| Measure | Description | Time Frame |
|---|---|---|
| incremental detection rate for advanced neoplasia and any polyp | per lesion analysis, the incremental detection rate for advance neoplasia and any polyp. In the per patient analysis, the increment in adenoma detection rate and any polyp detection rate. | From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Ramat Gan | 5262000 | Israel |
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| ID | Term |
|---|---|
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D001185 | Artificial Intelligence |
| ID | Term |
|---|---|
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
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comparison of 2 groups of patients undergoing tandem colonoscopy
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| The increment in adenoma detection rate / polyp detection rate | per lesion analysis, the incremental detection rate for advance neoplasia and any polyp. In the per patient analysis, the increment in adenoma detection rate and any polyp detection rate. | From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).] |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |