RIRS With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini PCNLfor Kidney Stones
- Conditions
- Kidney Stone
- Interventions
- Procedure: RIRS
- Registration Number
- NCT06209931
- Lead Sponsor
- The Affiliated Ganzhou Hospital of Nanchang University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description RIRS RIRS Patients were performed under general anesthesia in the oblique supine lithotomy position. Initially, preliminary ureteroscopy was performed with a semirigid 8/9.8 Fr ureteroscope guided by zebra guide wire. Next, the patented tip flexible pressure-controlling ureteral access sheath (UAS,12/14 Fr) was inserted along the guidewire without the fluoroscopic guidance. The fully automatic mode was chosen to operate the platform.The pressure sensory and suctioning channels of UAS were connected to the irrigation and suctioning platform. After water injection, zero calibration was performed at platform. Perfusion flow rate was then set at 100-150 ml/min, the renal pelvic pressure (RPP) control value was set at -15\~5 mmHg, the RPP warning value was set at 20 mmHg, and the RPP maximum value was set at 30 mmHg. Intraoperatively, a holmium laser was used to crush the stone at 1.5-2.0 J/pulse with a frequency of 20-30 pulses/s ( (CHUNHUI, CHINA, 276µm).
- Primary Outcome Measures
Name Time Method Operation time the time from the insertion of the suction sheath and renal puncture to the end of the operation,assessed up to 90 minutes. The operation time of RIRS and mini PCNL was defined as the time from the insertion of the suction sheath and renal puncture to the end of the operation
Immediate stone-free rate Postoperative day 1-7 No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1-7 are defined as stone free.
Complications up to 3 months post Postoperative 3 month Stone-free rate at 1 months Postoperative 1 month No residual stone or stone fragments less than 2 mm on kidney, ureter, and bladder at 1 months are defined as stone free.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Xiaolin Deng
🇨🇳Ganzhou, Jiangxi, China