Diagnostic Accuracy of EUS for Colorectal Submucosal Masses

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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Key information

Conditions

Colorectal Subepithelial Lesions

Sex eligibility

All sexes

Study type

Observational

Primary location

Shenzhen, Guangdong, 518000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic Ultrasound (EUS) Assessment

Other

Primary outcomes

Coincidence Rate Between Endoscopic Ultrasound Diagnosis and Pathological Diagnosis

Time frame: At the time of preoperative EUS and postoperative pathological evaluation (Day 0).

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.

Sponsors and collaborators

Lead sponsor

Run-hua Li

Other

Registry information

Official study title

Study on the Diagnostic Accuracy of Endoscopic Ultrasound for Submucosal Masses of Colorectal Cancer

Important dates

Study start: 2015
Primary completion: 2023
Study completion: 2023
First posted: Jan 20, 2026
Registry last updated: Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.