Diagnostic Accuracy of EUS for Colorectal Submucosal Masses

NCT07351890 | Completed

• 1 other identifier: NYSZYYEC20230088
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Subepithelial Lesions

Outcome Measures

Primary Outcomes (1)

• 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).

Interventions

Endoscopic Ultrasound (EUS) Assessment OTHER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Run-hua Li: lead

Study Sites (1)

Unknown Facility

Shenzhen, Guangdong, 518000, China

Location

Related Links

• Related Info

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 20, 2026
• Study Start: January 1, 2015
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 20, 2026

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)