Flexible Ureteroscopy With Tip-bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2-3cm Renal Stones
NCT Number: NCT06526390
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urolithiasis|Kidney Stone
Interventions: PROCEDURE: f-URS|PROCEDURE: mini-PCNL
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Collaborators: University of Malaya|Ankara University|Saint Petersburg State University Hospital|Fortune Urology Clinic|Guizhou Provincial People's Hospital|Baoshan No.2 People's Hospital|Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|First Affiliated Hospital, Sun Yat-Sen University|The First Affiliated Hospital with Nanjing Medical University|Shengjing Hospital|The Second Affiliated Hospital of Harbin Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 720
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-10-31

Summary:
Background: Percutaneous nephrolithotomy (PCNL) is the first-line treatment for renal stones larger than 2 cm according to EAU and AUA guidelines. Advances in flexible ureteroscopy, including smaller disposable ureteroscopes and suction techniques, have expanded its indications. The tip-bendable suction ureteral access sheath (S-UAS) offers improved flexibility and stone-free rates (SFR). This study compares clinical outcomes of flexible ureteroscopy (f-URS) with S-UAS and mini-PCNL in treating 2-3 cm renal stones.

Objective: This study aims to determine if f-URS with S-UAS is non-inferior to mini-PCNL regarding stone-free rates. Secondary objectives include comparing complication rates, surgical time, and hospitalization duration.

Methods: This multicenter, international, prospective, non-inferiority, randomized controlled trial will enroll 770 patients across 11 urological centers. Patients will be randomized to either f-URS with S-UAS or mini-PCNL. Outcomes include immediate and 3-month SFR, operative time, hospital stay, further interventions, complications, and quality of life.

Results: Data will be analyzed using intention-to-treat and per-protocol approaches, with statistical analyses performed using SPSS software.

Conclusion: This study will provide high-level evidence on the effectiveness of f-URS with S-UAS compared to mini-PCNL for medium-sized renal stones.

Primary Outcome Measures: Immediately stone-free rate (SFR), No residual stone visualized under endoscopy and no residual stone or stone fragments less than 2 mm on low dose CT scan with a 2-mm section thickness within postoperative 24 hours are defined as stone free., Up to 24 hours.
Secondary Outcome Measures: Final SFR, SFR at 3 months postoperative based on CT scans., 3 months.|Operative time, Operative time., through operation completion, an average of 1 hour|Duration of hospital stay, Rounded to the nearest whole day and calculated from the day of surgery to the day of discharge., Up to 3 months.|Further interventions (Second-look PCNL or RIRS or SWL), Further interventions, Up to 3 months.|Complications, Complications, Up to 3 months.|Improvement of Quality of Life Score, Improvement of Quality of Life Score, Up to 3 months.