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Status unknownNCT04645472Updated Nov 27, 2020

CT-Ultrasound Fusion in Guiding PCNL Puncture

An observational study in Kidney Stone, sponsored by Zhenyu Wu. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-27.

Sponsored by Zhenyu Wu · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
70
Ages
18 Years to 80 Years
Sex
All
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Study summary

Kidney stone is a common urological disease. Percutaneous nephrolithotomy (PCNL) is an important method for the treatment of kidney stones. The accuracy of puncture positioning affects the PCNL stone free rate and intraoperative/postoperative complications. Currently, PCNL puncture positioning methods are mainly X-ray-guided or ultrasound-guided. The main disadvantage of X-ray is the lack of soft tissue imaging, and the problem of low puncture accuracy. Although ultrasound is a commonly used real-time imaging tool, the image is not intuitive enough, and the puncture path is deviated from actual requirements . In order to improve the accuracy of PCNL puncture, this study intends to import CT images of both kidneys into a novel ultrasound machine through an image fusion system to achieve CT-ultrasound image fusion, and to simulate the puncture route to guide the PCNL puncture process. The study is mainly divided into two parts: (1) For patients with kidney stones who are planning to undergo PCNL, perform a preoperative simulated CT-ultrasound fusion examination to further clarify the condition of the kidney stones and simulate and optimize the puncture route; (2) Apply CT- Ultrasound fusion precise positioning to guide the intraoperative PCNL puncture process. On the basis of traditional ultrasound images, the CT-ultrasound fusion image display is added to provide the optimal puncture route to explore the effectiveness and safety of CT-ultrasound fusion precise positioning in PCNL puncture.

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Conditions studied

  • Kidney Stone

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In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's planned enrollment of 70 is below the median of 144 across 110 observational studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

This is the only study on the registry with Zhenyu Wu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

We plan to enroll 50 patients to explore the effectiveness and safety of CT-ultrasound fusion in guiding PCNL puncture positioning.

Inclusion criteria

  • (1) Age ≥18 years old, gender is not limited, and can tolerate surgery; (2) Kidney stone patients who intend to undergo PCNL surgery; (3) Have kidney CT data; (4) Volunteer to participate and sign informed consent.

Exclusion criteria

Exclusion Criteria:

  • (1) Uncontrollable systemic hemorrhagic disease; (2) Severe spinal deformity, severe hip deformity, and difficult lithotomy position; (3) Uncontrolled urinary tract infection; (4) Cavity caused by any urinary system anatomy Internal surgery cannot be performed; (5) Pregnant women, women who plan to become pregnant within 3 months, and lactating women; (6) Patients with severe heart, lung and brain diseases that cannot tolerate surgery; (7) The investigator judges that the patient is not suitable for participating in this study , Including (but not limited to): known to be carrying human immunodeficiency virus or suffering from AIDS; suffering from mental illness; infectious diseases, etc.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • CT-Ultrasound group

    Device: CT-Ultrasound

Interventions

  • DeviceCT-Ultrasound

    For patients with kidney stones who are planning to undergo PCNL, perform a preoperative simulated CT-ultrasound fusion examination to further clarify the condition of the kidney stones and simulate and optimize the puncture route. Apply CT- Ultrasound fusion precise positioning to guide the intraoperative PCNL puncture process.

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What researchers measure

Primary outcomes

  1. Stone free rate

    Stone free rate in a week

    Time frame: in a week

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Study locations

1 of 1 sites recruiting
  • Zhenyu Wu
    Guangzhou, Guangdong 510000, China
    Recruiting
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References and documents

Publications

  • Rizvi SAH, Hussain M, Askari SH, Hashmi A, Lal M, Zafar MN. Surgical outcomes of percutaneous nephrolithotomy in 3402 patients and results of stone analysis in 1559 patients. BJU Int. 2017 Nov;120(5):702-709. doi: 10.1111/bju.13848. Epub 2017 Apr 17. PubMed 28303631 ↗
  • Kalogeropoulou C, Kallidonis P, Liatsikos EN. Imaging in percutaneous nephrolithotomy. J Endourol. 2009 Oct;23(10):1571-7. doi: 10.1089/end.2009.1521. PubMed 19630501 ↗
  • Ghani KR, Andonian S, Bultitude M, Desai M, Giusti G, Okhunov Z, Preminger GM, de la Rosette J. Percutaneous Nephrolithotomy: Update, Trends, and Future Directions. Eur Urol. 2016 Aug;70(2):382-96. doi: 10.1016/j.eururo.2016.01.047. Epub 2016 Feb 11. PubMed 26876328 ↗
  • Xu ZF, Xie XY, Kuang M, Liu GJ, Chen LD, Zheng YL, Lu MD. Percutaneous radiofrequency ablation of malignant liver tumors with ultrasound and CT fusion imaging guidance. J Clin Ultrasound. 2014 Jul-Aug;42(6):321-30. doi: 10.1002/jcu.22141. Epub 2014 Feb 25. PubMed 24615771 ↗
  • Da Rosa MR, Milot L, Sugar L, Vesprini D, Chung H, Loblaw A, Pond GR, Klotz L, Haider MA. A prospective comparison of MRI-US fused targeted biopsy versus systematic ultrasound-guided biopsy for detecting clinically significant prostate cancer in patients on active surveillance. J Magn Reson Imaging. 2015 Jan;41(1):220-5. doi: 10.1002/jmri.24710. Epub 2014 Jul 21. PubMed 25044935 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04645472
Lead sponsor
Zhenyu Wu
Responsible party
Zhenyu Wu (Medical Doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University) — Sponsor-investigator
First posted
Nov 27, 2020
Start date
Apr 20, 2020
Primary completion
Mar 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Nov 27, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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