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| Name | Class |
|---|---|
| Beijing Friendship Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
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The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to identify patients with high risk adenomas during colonoscopy to guide proper follow-up strategy. 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 identification of patients with high risk adenomas? What adverse events do participants experience during colonoscopy? 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 high risk adenoma identification.
Participants will:
Undertake colonoscopy examination 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 colonoscopy examination using 2D imaging colonoscope |
|
| 3D imaging arm | Experimental | participants will undergo colonoscopy examination using 3D imaging colonoscope |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy after bowel cleansing with 2D imaging device | Procedure | participants will undergo colonoscopy examination using 2D imaging colonoscope to detect potential adenomas or polyps. The classification of the detected lession will be determined by the edoscopic diagnosis based on the JNET classification system or by the pathological diagnosis with tissues from biopsy or polypectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| High-risk adenoma (HRA) detection rate | HRA were defined with one of the following features:1. diameter ≥10 mm or 2. (tubulo)villous adenomas or 3. with high-grade dysplasia or 4. sessile serrated lesions (SSLs) or 5. ≥ 3 adenomas. SSLs were defined as lesions with at least one crypt showing a characteristic sessile serrated lesion-type appearance. HRA detection rate is defined as the number of participants diagnosed with HRA divided by the total number of participants | 1-7 days after polypectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate (ADR) | The number of participants with at least 1 adenoma divided by the total number of participants | 1-7 days after polypectomy |
| Polyp detection rate (PDR) | The number of participants with at least 1 polyp divided by the total number of participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhiguo Liu, M.D | Contact | 86-29-84771535 | liuzhiguo@fmmu.edu.cn | |
| Jiaqiang Dong, M.D | Contact | 86-29-84771517 | dongjiaqiang1988@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhiguo Liu, M.D | Xijing Hospital of Digestive Disease | Principal Investigator |
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| Colonoscopy after bowel cleansing with 3D imaging device | Procedure | participants will undergo colonoscopy examination using 3D imaging colonoscope to detect potential adenomas or polyps. The classification of the detected lession will be determined by the edoscopic diagnosis based on the JNET classification system or by the pathological diagnosis with tissues from biopsy or polypectomy. |
|
| 1-7 days after polypectomy |
| Clinically relevant serrated polyp detection rate | Clinically relevant serrated polyps are defined as ≥10 mm serrated polyps (SPs, including hyperplastic polyps, SSLs, and traditional serrated adenomas) and >5 mm SPs in the proximal colon. Clinically relevant serrated polyp detection rate is defined as the number of participants with at least 1 clinically relevant serrated polyp divided by the total number of participants. | 1-7 days after polypectomy |
| Modified advanced adenoma detection rate | Modified advanced adenoma are defined with one of the following features:1. diameter ≥10 mm or 2. (tubulo)villous adenomas or 3. with high-grade dysplasia or 4. sessile serrated lesions (SSLs). SSLs were defined as lesions with at least one crypt showing a characteristic sessile serrated lesion-type appearance. Modified advanced adenoma detection rate is defined as the number of participants diagnosed with modified advanced adenoma divided by the total number of participants | 1-7 days after polypectomy |
| Advanced adenocarcinoma detection rate | Advanced adenocarcinoma is defined as adenocarcinoma with submucosal invasion more than 1000μm (SM2). Advanced adenocarcinoma detection rate is defined as the number of participants diagnosed with advanced adenocarcinoma divided by the total number of participants | 1-7 days after polypectomy |
| The number of lesions per colonoscopy | The number of lesions per colonoscopy was defined as the number of corresponding lesions (adenoma, polyp, clinically relevant serrated polyps, et al)divided by the total number of colonoscopies or participants | 1-7 days after polypectomy |
| Lesion detection rate in different location | Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate in different location of colon and rectum | 1-7 days after polypectomy |
| Lesion detection rate in different size | Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate in different size (≤3mm, 3-10mm, >10mm) | 1-7 days after polypectomy |
| Lesion detection rate in different type | Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate in different type (Paris classification) | 1-7 days after polypectomy |
| Lesion detection rate by endoscopists of different experience | Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate by endoscopists of different experience (senior or junior) | 1-7 days after polypectomy |
| Cecal intubation time | Cecal intubation time (CIT) is defined as the time from the insertion of the colonoscope tip into the anal verge until reaching the cecal base or cecal end | immediately during the colonoscopy examination procedure |
| Withdrawal time | Withdrawal time is defined as the time from reaching the cecal base or cecal end to the endoscope withdrawal to the anal verge, excluding the time of polypectomy | immediately during the colonoscopy examination procedure |
| 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 |