CT-Ultrasound Fusion in Guiding PCNL Puncture

• Conditions: Kidney Stone
• Interventions: Device: CT-Ultrasound

• Registration Number: NCT04645472
• Lead Sponsor: Zhenyu Wu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-20
• Status Verified: 2020-11
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Study First Posted: 2020-11-27
• Last Update Posted: 2020-11-27
• Primary Completion: 2021-03
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

• (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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CT-Ultrasound group	CT-Ultrasound	-

Primary Outcome Measures

Name	Time	Method
Stone free rate	in a week	Stone free rate in a week

Trial Locations

Locations (1)

Zhenyu Wu; 🇨🇳 Guangzhou, Guangdong, China