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This study aims to evaluate the diagnostic accuracy of endoscopic ultrasound (EUS) for colorectal submucosal tumors/lesions (SMTs/SELs) and to identify factors associated with correct EUS diagnosis. Using cases with histopathologic confirmation as the reference standard, EUS-based preoperative diagnoses will be compared with final pathology to estimate overall accuracy and accuracy across different lesion types. Potential influencing factors-including lesion location, size, echogenicity, layer of origin, image quality, operator experience and training, and EUS equipment/probe type-will be analyzed to determine independent predictors of diagnostic concordance. The findings are expected to inform optimization of EUS examination and interpretation for colorectal submucosal lesions, thereby improving clinical decision-making and overall quality of care.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Ultrasound (EUS) Assessment | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Coincidence Rate Between Endoscopic Ultrasound Diagnosis and Pathological Diagnosis | For each included lesion with histopathologic confirmation, the preoperative endoscopic ultrasound (EUS) diagnosis will be compared with the final pathological diagnosis. The coincidence rate will be calculated as the proportion of lesions in which the EUS diagnosis is concordant with the pathological diagnosis (number of concordant diagnoses divided by the total number of lesions assessed) during the study period. | At the time of preoperative EUS and postoperative pathological evaluation (Day 0). |
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Inclusion Criteria:
Exclusion Criteria:
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This study includes patients who were admitted to Shenzhen Hospital of Southern Medical University between 2015 and 2023 and underwent colorectal endoscopic ultrasound (EUS). Eligible participants are those diagnosed with colorectal submucosal tumors/subepithelial lesions based on the Chinese expert consensus on endoscopic diagnosis and treatment of gastrointestinal submucosal tumors (2023 edition) and related criteria. Patients whose EUS findings did not support a diagnosis of a submucosal tumor/subepithelial lesion were excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen | Guangdong | 518000 | China |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2023 | Dec 31, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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