- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07299643
Application of 3DSlicer Technology in Percutaneous Nephrolithotomy Surgery.
The Application of 3DSlicer Technology in Percutaneous Nephrolithotomy Surgery.
Objectives: Percutaneous nephrolithotomy (PCNL) has become a widely used technique for managing renal calculi. However, the rate of residual stones remains high. Accurate preoperative assessment of the individual's renal collecting system anatomy and strategic planning of access pathways are essential for improving stone-free outcomes. This study investigated whether characteristics of the target calyx can predict stone clearance through a distinct puncture calyx and developed a model to estimate the risk of residual stones in the target calyx.
Methods: We performed a retrospective analysis of patients who underwent PCNL in the urology department of our center between January 2023 and June 2025, in whom the puncture calyx differed from the target calyx (67 cases with complete stone clearance and 38 cases with residual stones). Three-dimensional reconstructions of the renal collecting system and calculi were generated from preoperative urinary tract CT scans, and spatial parameters were obtained from these models. Patient and stone characteristics were combined with 3D-derived variables for binary logistic regression to identify predictive factors and construct nomograms. Model performance was assessed using receiver operating characteristic (ROC) and calibration curves, while clinical utility was evaluated through decision curve analysis (DCA). The Youden index was applied to determine the optimal cutoff value.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zhejiang
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Jinhua, Zhejiang, China, 321000
- Department of Urology, Affiliated Jinhua Hospital, Zhejiang University School of Medicine,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
① preoperative diagnosis of renal calculi confirmed by computed tomography urography (CTU); ② completion of standard-channel (F24) PCNL with the puncture and target calyces situated in different renal calyces; and ③ postoperative CT imaging performed within one week after surgery.
Exclusion Criteria:
① anatomical abnormalities of the affected kidney, such as severe renal rotation or horseshoe kidney; and ② history of secondary procedures, including repeat PCNL or renal puncture with fistula formation.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Stone Free Group
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Stone Residue Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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predict the stone free possibility of kidey stone
Time Frame: 2023-2025
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AUC curve
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2023-2025
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predict the stone free possibility of kidey stone
Time Frame: 2023-2025
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DCA curve
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2023-2025
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022282
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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