CT-Ultrasound Fusion in Guiding PCNL Puncture

NCT04645472 | Unknown

• 1 other identifier: 2020-KY-021
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Stone

Outcome Measures

Primary Outcomes (1)

• Stone free rate

  Stone free rate in a week

  in a week

Study Arms (1)

CT-Ultrasound group

Device: CT-Ultrasound

Interventions

CT-Ultrasound DEVICE

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.

CT-Ultrasound group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Zhenyu Wu: lead

Study Sites (1)

Zhenyu Wu

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 28303631 BACKGROUND

• Kalogeropoulou C, Kallidonis P, Liatsikos EN. Imaging in percutaneous nephrolithotomy. J Endourol. 2009 Oct;23(10):1571-7. doi: 10.1089/end.2009.1521.

  PMID: 19630501 BACKGROUND

• 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.

  PMID: 26876328 BACKGROUND

• 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.

  PMID: 24615771 BACKGROUND

• 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.

  PMID: 25044935 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: November 27, 2020
• Study Start: April 20, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)