NCT07299643

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

December 10, 2025

Last Update Submit

December 10, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • predict the stone free possibility of kidey stone

    AUC curve

    2023-2025

  • predict the stone free possibility of kidey stone

    DCA curve

    2023-2025

Study Arms (2)

Stone Free Group

Stone Residue Group

Eligibility Criteria

Age28 Years - 77 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

After applying these criteria, a total of 105 renal calyces were included for analysis

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Affiliated Jinhua Hospital, Zhejiang University School of Medicine,

Jinhua, Zhejiang, 321000, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2025

First Posted

December 23, 2025

Study Start

January 1, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations