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| Name | Class |
|---|---|
| Heilongjiang Provicial Hospital | OTHER |
| Ankang Central Hospital | OTHER |
| Huadong Hospital Affiliated with Fudan University, Shanghai | UNKNOWN |
| The First Affiliated Hospital of Nanchang University |
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Colorectal cancer (CRC) is the third most common malignancy globally. Sessile serrated lesions (SSLs) account for 15-30% of CRC via the serrated pathway. Accurate SSL diagnosis relies on basal crypt features, which are often obscured by specimen curling during standard formalin fixation, leading to underdiagnosis. A novel polyp pretreatment device mechanically maintains mucosal flatness, ensuring vertical sectioning relative to the muscularis mucosae. This randomized, double-blind, parallel-controlled trial evaluates whether the device improves SSL diagnostic rate and section orientation in sessile colorectal polyps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyp Pretreatment Device | Experimental |
| |
| Standard Processing | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyp Pretreatment Device | Device | This novel polyp pretreatment device is a single-use, non-invasive laboratory tool designed to standardize the orientation and fixation of resected colorectal polyp specimens. The device consists of a flat, rigid base with a transparent, non-adherent cover, and is engineered to maintain the mucosal surface of the polyp specimen flat and fully extended. |
| Measure | Description | Time Frame |
|---|---|---|
| SSL Diagnostic Rate (%) | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaoshen Li | Contact | 86-021-31161365 | li.zhaoshen@hotmail.com | |
| Yu Bai | Contact | 86-021-31161335 | baiyu1998@hotmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39351466 | Background | Tran TH, Nguyen VH, Vo DT. How to "pick up" colorectal serrated lesions and polyps in daily histopathology practice: From terminologies to diagnostic pitfalls. World J Clin Oncol. 2024 Sep 24;15(9):1157-1167. doi: 10.5306/wjco.v15.i9.1157. | |
| 26501882 | Background | Kolb JM, Morales SJ, Rouse NA, Desai J, Friedman K, Makris L, Bamji ND, Miller KM, Soetikno RM, Kaltenbach T, Rouse RV, Aisenberg J. Does Better Specimen Orientation and a Simplified Grading System Promote More Reliable Histologic Interpretation of Serrated Colon Polyps in the Community Practice Setting? Results of a Nationwide Study. J Clin Gastroenterol. 2016 Mar;50(3):233-8. doi: 10.1097/MCG.0000000000000413. |
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| OTHER |
| Ya'an People's Hospital | UNKNOWN |
| The Second Hospital of Hebei Medical University | OTHER |
| Chongqing General Hospital | OTHER |
| Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital) | UNKNOWN |
| Shanxi Provincial People's Hospital | OTHER_GOV |
| Shanghai Sixth Hospital | UNKNOWN |
| People's Hospital of Leshan, Sichuan Province | UNKNOWN |
| The Third People's Hospital of Chengdu | OTHER |
| The Third People's Hospital of Jingdezhen | UNKNOWN |
| Ningbo Hospital of Integrated Traditional Chinese and Western Medicine | UNKNOWN |
| Shandong Provincial Hospital | OTHER_GOV |
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| 24165815 | Background | Morales SJ, Bodian CA, Kornacki S, Rouse RV, Petras R, Rouse NA, Cohen LB, Bamji ND, Miller KM, Soetikno RM, Kaltenbach T, Aisenberg J. A simple tissue-handling technique performed in the endoscopy suite improves histologic section quality and diagnostic accuracy for serrated polyps. Endoscopy. 2013 Nov;45(11):897-905. doi: 10.1055/s-0033-1344435. Epub 2013 Oct 28. |