URSL Angle for Predicting Intraoperative Conversion
ConditionUreteral Calculi
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Hospital of Jilin University
About this trial
This international multicenter retrospective cohort study aims to externally validate the URSL Predictive Angle, a novel CT-derived morphometric parameter, as an imaging biomarker for predicting intraoperative conversion risk during transurethral ureteroscopic lithotripsy (URSL) for ureteral calculi.
Intraoperative conversion is defined as the unanticipated abandonment of the planned endoscopic approach due to unfavorable ureteral anatomy or stone impaction, necessitating recourse to open ureterolithotomy, laparoscopic ureterolithotomy, or ureteral stent placement with planned staged secondary intervention. Such conversions are associated with protracted operative duration, heightened anesthetic exposure, and increased physical, psychological, and financial burdens on patients.
The URSL Predictive Angle is a geometric parameter derived from preoperative coronal CT reformations that quantifies the degree of local ureteral angulation induced by an impacted calculus. Preliminary single-center data demonstrated robust predictive fidelity of this metric with an area under the ROC curve of 0.861 and an optimal discriminatory threshold of 131.8° yielding a sensitivity of 82% and a specificity of 88%.
This study will enroll eligible patients from multiple domestic and international tertiary care hospitals who underwent URSL for ureteral calculi between January 1, 2018, and December 31, 2025. The primary outcome is intraoperative conversion of surgical approach. The predictive performance of the URSL angle will be evaluated using ROC curve analysis with AUC calculation. Propensity score matching and multivariable logistic regression will be employed to address potential confounding.
This study is registered as a patient registry with a cohort model. Data collection is retrospective, involving abstraction from electronic medical records, operative logs, and PACS. A waiver of informed consent has been requested based on the retrospective design, minimal risk determination, stringent anonymization procedures, and impracticability of obtaining individual consent.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years at the time of surgery, without restriction based on sex, ethnicity, or occupation.
Preoperative imaging confirmation of unilateral, solitary, or unilateral multiple ureteral calculi. In cases of ipsilateral multiple stones, the calculus deemed primarily responsible for obstruction or designated as the principal surgical target shall serve as the index stone.
Planned and attempted transurethral ureteroscopic lithotripsy as the initial treatment modality.
Availability of preoperative thin-slice (section thickness ≤ 1.25 mm) computed tomography urography or non-contrast CT of the urinary tract in native Digital Imaging and Communications in Medicine (DICOM) format, of sufficient diagnostic quality to permit multiplanar reconstruction and precise morphometric analysis. Image data must be complete and free from substantial motion or beam-hardening artifact that would preclude accurate delineation of ureteral anatomy.
Disqualifiers
1.Absence of preoperative CT imaging performed at the participating institution; missing, corrupted, or irretrievable DICOM data; or suboptimal image quality that precludes reliable ureteral segmentation and measurement.
Trial population
All participating centers are required to maintain established expertise in ureteroscopic surgical techniques, robust clinical data management infrastructure, and comprehensive archival systems for preoperative computed tomography imaging. Each center shall formally assent to and comply with the unified study protocol, thereby ensuring data completeness, source traceability, and adherence to international ethical standards. Eligible patient records will be retrieved for the period spanning January 1, 2018, to December 31, 2025 (inclusive, encompassing an eight-year interval). All patients who underwent URSL for ureteral calculi and satisfied the stipulated eligibility criteria during this timeframe will be considered for inclusion.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
2,200 Participants
are grouped into 2 trial groupsGroup A: Success Group
Group B: Conversion Group
Trial outcomes
Primary outcomes
1
Intraoperative Conversion of Surgical Approach
Unanticipated abandonment of the planned transurethral ureteroscopic lithotripsy procedure due to technical impediments directly attributable to unfavorable ureteral anatomy or calculus impaction, necessitating intraoperative recourse to an alternative surgical modality. Alternative modalities include open ureterolithotomy, laparoscopic ureterolithotomy, or ureteral stent placement with planned staged secondary intervention. Conversions due to equipment malfunction, hemodynamic instability, or other non-anatomic etiologies are excluded. Outcome will be ascertained by retrospective review of operative records.
Time frame
At the time of surgery, as documented in the operative recordLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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