Clinical trial NCT06209931: RIRS With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini PCNLfor Kidney Stones
Official title: Retrograde Intrarenal Surgery With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini Percutaneous Nephrolithotomy for the Treatment of 2-3-cm Kidney Stones
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Stone
Lead sponsor: The Affiliated Ganzhou Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney stones were confirmed in all patients by imaging, including urinary tract ultrasonography, intravenous urography, and computed tomography (CT). Stone size was calculated by CT scans.

Brief summary: The goal of this observational study is to compare the safety and efficacy between RIRS with tip flexible pressure-controlling ureteral access sheath and mini percutaneous nephrolithotripsy（PCNL） for the treatment of 2-3-cm kidney stones.

Detailed description: Retrograde Intrarenal Stone Surgery (RIRS) has become one of the most common treatments for renal stones. The development of ureteral access sheath (UAS) is a significant advance in RIRS. In recent years, various improvements have been made to UAS, especially the emergence of a suction UAS and a tip flexible UAS. Using the advantages of suction and tip flexible technology, our team developed a tip flexible pressure-controlling UAS, which significantly improves the safety and effectiveness of RIRS. However, the current guidelines can recommend the indication of RIRS in kidney stones less than 2cm, and percutaneous nephrolithotomy(PCNL) is still preferred for kidney stones larger than 2 cm. Therefore, this study is the first to compare the safety and efficacy between RIRS with tip flexible pressure-controlling UAS and mini PCNL in the treatment of 2 to 3 cm kidney stones.

Eligibility 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.

Primary outcomes:
measure: Immediate stone-free rate
timeFrame: Postoperative day 1-7
measure: Stone-free rate at 1 months
timeFrame: Postoperative 1 month
measure: Complications up to 3 months post
timeFrame: Postoperative 3 month
measure: Operation time
timeFrame: the time from the insertion of the suction sheath and renal puncture to the end of the operation,assessed up to 90 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Ganzhou
country: China
facility: Xiaolin Deng
state: Jiangxi
Study officials:
affiliation: The Affiliated Ganzhou Hospital of Nanchang University
name: Leming Song
role: STUDY_CHAIR
References: