RIRS With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini PCNLfor Kidney Stones

The Affiliated Ganzhou Hospital of Nanchang University

Status: Enrolling

Conditions: Kidney Stone

Treatments: Procedure: RIRS

Study type: Observational

Funder types: Other

Identifiers

NCT06209931

TY-ZKY-2023-045-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

160 participants in 2 patient groups

RIRS

Description:

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).

Treatment:

Procedure: RIRS

MPCNL

Description:

Patients were performed under general anesthesia. The patient was first placed in a lithotomy position. A 5 Fr ureteral catheter was then inserted retrogradely into the renal pelvis through cystoscopy or ureteroscopy , and saline was continuously infused to produce artificial hydronephrosis. The patient was then placed in the prone position. Ultrasound-guided percutaneous punctures were made with an 18-gauge coaxial needle into the targeted calix. The puncture point was in the 12th rib infracostal margin, between the posterior axillary line and scapula line. A Zebra guidewire was inserted and fixed. The puncture needle was then removed. After a 0.5-0.7 cm skin incision was made, the percutaneous tract was dilated serially over the guidewire with a fascial dilator to 18Fr. Holmium laser lithotripsy at 1.5-2.0 J/pulse with a frequency of 20-30 pulses/s (CHUNHUI, CHINA, 550µm) was performed with a 18 Fr peel-away sheath.