Percutaneous NephrolithotomyNCT07299643
Application of 3DSlicer Technology in Percutaneous Nephrolithotomy Surgery.
An observational study of Percutaneous Nephrolithotomy, run by Ting Huang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 28 to 77 years
- Conditions the study is for
- Percutaneous Nephrolithotomy
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: After applying these criteria, a total of 105 renal calyces were included for analysis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Urology, Affiliated Jinhua Hospital, Zhejiang University School of Medicine,
Jinhua, Zhejiang, 321000
About this study
Official title: 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.
- Conditions
- Percutaneous Nephrolithotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stone Free Group | Not described | |
| Stone Residue Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
predict the stone free possibility of kidey stone
AUC curve
Measured: 2023-2025
predict the stone free possibility of kidey stone
DCA curve
Measured: 2023-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Jan 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ting Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ting Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299643
- Sponsor's protocol ID
- 2022282
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of 3DSlicer Technology in Percutaneous Nephrolithotomy Surgery.
- ClinicalTrials.gov ID
- NCT07299643
- Acronym / sponsor ID
- 2022282
- Conditions
- Percutaneous Nephrolithotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Ting HuangUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stone Free Group | – | – |
| Stone Residue Group | – | – |
Who may qualify
- Ages
- 28 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- After applying these criteria, a total of 105 renal calyces were included for analysis
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
predict the stone free possibility of kidey stone
Time frame: 2023-2025
AUC curve
predict the stone free possibility of kidey stone
Time frame: 2023-2025
DCA curve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Safety, Efficacy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Nephrolithotomy, run by Ting Huang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predict the stone free possibility of kidey stone (time frame: 2023-2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.