跳至主要内容
临床试验/NCT04645472
NCT04645472Unknown不适用

Accurate Positioning of CT-Ultrasound Fusion in PCNL Puncture Guidance

Zhenyu Wu1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年4月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
1
主要终点
Stone free rate

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (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.

排除标准

  • (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.

结局指标

主要结局

Stone free rate

时间窗: in a week

Stone free rate in a week

次要结局

未报告次要终点

研究者

发起方
Zhenyu Wu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhenyu Wu

Medical Doctor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

Loading locations...

相似试验

CT-Ultrasound Fusion in Guiding PCNL Puncture | 临床试验