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

Kidney Stone Clinical Trial

Official title:

Retrograde Intrarenal Surgery With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini Percutaneous Nephrolithotomy for the Treatment of 2-3-cm Kidney Stones

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06209931
• Other study ID #: TY-ZKY-2023-045-12
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: The Affiliated Ganzhou Hospital of Nanchang University
• Contact: Xin Huang, M.D.
• Phone: 0086-0797-5889867
• Email: sysuhuangxin[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2024
• Est. primary completion date: October 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

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

Locations

Country	Name	City	State
China	Xiaolin Deng	Ganzhou	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Ganzhou Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Complications up to 3 months post		Postoperative 3 month
Primary	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.