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The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to correctly classify colon polyps and adenomas during colonoscopy to guide the selection of proper treatment procedures. It will also learn about the safety of 3-dimensional (3D) imaging device. The main questions it aims to answer are:
Does 3-dimensional (3D) imaging device improve the correct classification as well as size and depth evaluation of polyps and adenomas during colonoscopy using pathology as gold standard? What adverse events do participants experience during colonoscopy and polypectomy?
Researchers will compare 3-dimensional (3D) imaging device to traditional 2-dimensional (2D) imaging device to see if 3-dimensional (3D) imaging device works to improve classification and evaluation accuracy.
Participants will:
Undertake colonoscopy examination and polypectomy using 3-dimensional (3D) imaging device or 2-dimensional (2D) imaging device.
Be followed-up to 30 days to record potential colonoscopy-relevant adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2D imaging arm | Active Comparator | participants will undergo polypectomy (CSP, CFP, or EMR) using 2D imaging colonoscope |
|
| 3D imaging arm | Experimental | participants will undergo polypectomy (CSP, CFP, or EMR) using 3D imaging colonoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic evaluation of colorectal polyps and adenomas using 2D imaging colonoscope | Diagnostic Test | endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 2D imaging colonoscope |
| Measure | Description | Time Frame |
|---|---|---|
| Overall diagnostic accuracy of endoscopic polyp classification | The overall proportion of correct classifications by endoscopy (JNET vs. JNET+3D) compared to the gold standard (pathology) at the lesion level, across all polyp types | 1-7 days after polypectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of endoscopic classification for advanced polyps | The overall proportion of correct classifications by endoscopy compared to the gold standard (pathology) in lesion level about advanced polyps Advanced polyp was defined as having a conventional adenoma with size ≥10 mm or with high-grade dysplasia, or a sessile serrated lesion with size ≥10 mm or with dysplasia. | 1-7 days after polypectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiguo Liu, M.D | Xijing Hospital of Digestive DIsease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Disease | Xi'an | Shaanxi | 710032 | China |
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| endoscopic evaluation of colorectal polyps and adenomas using 3D imaging colonoscope | Diagnostic Test | endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 3D imaging colonoscope |
|
| Diagnostic accuracy of endoscopic classification for serrated lesions | The overall proportion of correct classifications by endoscopy (JNET vs. JNET+3D) compared to the gold standard (pathology) at the lesion level for serrated lesions | 1-7 days after polypectomy |
| Diagnostic accuracy of endoscopic classification for identifying patients requiring surveillance | patients with complete removal of at least 1 adenoma ≥ 10 mm or with high grade dysplasia, or ≥ 5 adenomas, or any serrated polyp ≥ 10 mm or with dysplasia | 1-7 days after polypectomy |
| Diagnostic characteristics (sensitivity, specificity, PPV, NPV, LR+, LR-) for advanced polyps | The following diagnostic accuracy measures will be calculated for endoscopic classification (JNET vs. JNET+3D) in detecting adenomas at the lesion level, using final pathology as the gold standard: Sensitivity Specificity Positive predictive value (PPV) Negative predictive value (NPV) Positive likelihood ratio (LR+) Negative likelihood ratio (LR-) | 1-7 days after polypectomy |
| The colonoscopy-relevant adverse events | aspiration pneumonia, perforation, bleeding, splenic injury/rupture, death, or others requiring hospitalization within 30 days after the colonoscopy | 1-30 days after polypectomy |