Diagnostic Accuracy of EUS for Colorectal Submucosal Masses

January 11, 2026 updated by: Run-hua Li

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the time of preoperative EUS and postoperative pathological evaluation (Day 0).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Run-hua Li

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYSZYYEC20230088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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