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

NCT06209931 | Unknown

• 1 other identifier: TY-ZKY-2023-045-12
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stone

Outcome Measures

Primary Outcomes (4)

• Immediate stone-free rate

  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.

  Postoperative day 1-7

• Stone-free rate at 1 months

  No residual stone or stone fragments less than 2 mm on kidney, ureter, and bladder at 1 months are defined as stone free.

  Postoperative 1 month

• Complications up to 3 months post

  Postoperative 3 month

• Operation time

  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

  the time from the insertion of the suction sheath and renal puncture to the end of the operation,assessed up to 90 minutes.

Study Arms (2)

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).

Procedure: RIRS

MPCNL

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.

Interventions

RIRS PROCEDURE

RIRS with tip flexible pressure-controlling ureteral access sheath versus mini PCNL for the treatment of 2-3-cm kidney stones

Also known as: MPCNL

RIRS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Ganzhou Hospital of Nanchang University: lead

Study Sites (1)

Xiaolin Deng

Ganzhou, Jiangxi, 341000, China

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Leming Song

  The Affiliated Ganzhou Hospital of Nanchang University

  STUDY CHAIR

Central Study Contacts

Xin Huang, M.D.

CONTACT

0086-0797-5889867; sysuhuangxin@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Senior Doctor

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: January 18, 2024
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

CN (1)