Diagnostic Accuracy of EUS for Colorectal Submucosal Masses

Run-hua Li

Status: Completed

Conditions: Colorectal Subepithelial Lesions

Treatments: Other: Endoscopic Ultrasound (EUS) Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT07351890

NYSZYYEC20230088

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who were admitted to Shenzhen Hospital of Southern Medical University from 2015 to 2023 and underwent colorectal endoscopic ultrasound.
• Patients diagnosed with colorectal submucosal tumors (subepithelial lesions) according to the Chinese expert consensus on the endoscopic diagnosis and treatment of gastrointestinal submucosal tumors (2023 edition).

Exclusion criteria

• Patients with endoscopic ultrasound diagnosis of non-submucosal tumors.

Trial design