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

Recruiting

• Conditions: Kidney Stone

• 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.

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-12-09
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-14
• Last Update Submitted: 2024-01-14
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18
• Primary Completion: 2024-10-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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.

Trial Locations

Locations (1)

Xiaolin Deng; 🇨🇳 Ganzhou, Jiangxi, China

Xiaolin Deng

🇨🇳Ganzhou, Jiangxi, China

Xiaolin Deng

Contact

+867975889867

279971368@qq.com