Comparing two methods for treating kidney stones between 2-3 cm.
Retrograde Intrarenal Surgery With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini Percutaneous Nephrolithotomy for the Treatment of 2-3-cm Kidney Stones
This study is testing which of two methods works better and is safer for treating kidney stones that are 2-3 cm in size.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Affiliated Ganzhou Hospital of Nanchang University Academic / other |
| Locations | 1 site (Ganzhou, Jiangxi) |
| Trial ID | NCT06209931 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the safety and efficacy of Retrograde Intrarenal Stone Surgery (RIRS) using a tip flexible pressure-controlling ureteral access sheath against mini percutaneous nephrolithotripsy (PCNL) for patients with kidney stones measuring 2-3 cm. The study leverages advancements in ureteral access sheath technology to enhance the treatment of renal stones. By evaluating these two approaches, the research seeks to provide insights into the most effective method for managing larger kidney stones, which are typically challenging to treat. This is the first study of its kind to directly compare these two techniques for this specific size of kidney stones.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with kidney stones measuring 2-3 cm.
Not a fit: Patients with abnormal urinary tract anatomy or uncontrolled urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with larger kidney stones, enhancing safety and efficacy.
How similar studies have performed: While RIRS has been widely used, this specific comparison with mini PCNL for 2-3 cm stones is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged ≥ 18 years * American Society of Anesthesiology score 1-2 * Kidney stone diameter of 2-3 cm confirmed by CT * Capable of giving written informed consent, which includes adherence with the requirements of the trial Exclusion Criteria: * Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit) * Patients with uncontrolled UTI * Patients with health or other factors that are absolute contraindications to RIRS or PCNL .Patients unable to understand or complete trial documentation.
Where this trial is running
Ganzhou, Jiangxi
- Xiaolin Deng — Ganzhou, Jiangxi, China (Recruiting)
Study contacts
- Study coordinator: Xin Huang, M.D.
- Email: sysuhuangxin@126.com
- Phone: 0086-0797-5889867
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.