Diagnostic Accuracy of EUS for Colorectal Submucosal Masses (NCT07351890) | Clinical Trial Compass
CompletedNot Applicable
Diagnostic Accuracy of EUS for Colorectal Submucosal Masses
China270 participantsStarted 2015-01-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Coincidence Rate Between Endoscopic Ultrasound Diagnosis and Pathological Diagnosis
Timeframe: At the time of preoperative EUS and postoperative pathological evaluation (Day 0).