RIRS With Flex Suction Sheath vs. PCNL for 2-3 cm Renal Stones

NCT07058402 | Recruiting DMC

• 1 other identifier: 20250408
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized controlled trial comparing retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath with standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones. The aim is to evaluate the clinical efficacy and safety of the novel suction sheath-assisted RIRS compared to standard PCNL in terms of stone-free rate and postoperative complications. A total of 308 patients will be enrolled across four centers in China.

Conditions

Nephrolithiasis

Keywords

Renal Calculi; Percutaneous Nephrolithotomy; PCNL; Retrograde Intrarenal Surgery; RIRS; Flexible Suction Access Sheath

Outcome Measures

Primary Outcomes (1)

• Stone-Free Rate (SFR)

  The proportion of participants who are stone-free after the procedure, defined as no residual stones or residual fragments \<2 mm based on postoperative plain abdominal X-ray or non-contrast CT scan.

  3 months postoperatively

Secondary Outcomes (1)

• Incidence of Postoperative Infection (SIRS Criteria)

  Within 72 hours postoperatively

Study Arms (2)

Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath

EXPERIMENTAL

Participants in this group will undergo retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath for the treatment of 2-3 cm unilateral renal stones.

Procedure: Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath

Standard Percutaneous Nephrolithotomy (PCNL)

EXPERIMENTAL

Participants in this group will undergo standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones.

Procedure: Standard Percutaneous Nephrolithotomy (PCNL)

Interventions

Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath PROCEDURE

Participants undergo retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath. The procedure involves the insertion of a flexible ureteroscope through the urethra and ureter into the kidney. A novel access sheath with tip-flexible and suction capabilities is used to facilitate stone fragmentation and removal. The goal is to improve stone clearance and reduce intrarenal pressure during the procedure.

Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath

Standard Percutaneous Nephrolithotomy (PCNL) PROCEDURE

Participants undergo standard percutaneous nephrolithotomy (PCNL). The procedure involves creating a percutaneous tract into the renal collecting system under imaging guidance, followed by nephroscope insertion to fragment and extract 2-3 cm renal stones. This represents the current standard of care for large renal calculi.

Also known as: RIRS with Tip-Flexible Suction Access Sheath

Standard Percutaneous Nephrolithotomy (PCNL)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years
• American Society of Anesthesiologists (ASA) physical status classification of I-III
• Single renal stone with a diameter between 2-3 cm confirmed by non-contrast CT scan
• Signed written informed consent and willingness to comply with study procedures

You may not qualify if:

• Anatomical abnormalities of the urinary tract (e.g., horseshoe kidney, ileal conduit)
• Uncontrolled urinary tract infection
• Absolute contraindications for RIRS or PCNL
• Inability to understand or complete study documentation
• Failure to follow study protocol or attend follow-up
• Patients requiring urgent rescue or at high risk for irreversible harm during surgery
• Patients who voluntarily withdraw from the study

Sponsors & Collaborators

• Changhai Hospital: lead
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator

Study Sites (1)

Changhai Hospital, Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (2)

• Skolarikos A, Jung H, Neisius A, et al. EAU Guidelines on Urolithiasis 2024. European Association of Urology. https://uroweb.org/guidelines/urolithiasis

  BACKGROUND

• Zeng G, Traxer O, Zhong W, Osther P, Pearle MS, Preminger GM, Mazzon G, Seitz C, Geavlete P, Fiori C, Ghani KR, Chew BH, Git KA, Vicentini FC, Papatsoris A, Brehmer M, Martinez JL, Cheng J, Cheng F, Gao X, Gadzhiev N, Pietropaolo A, Proietti S, Ye Z, Sarica K. International Alliance of Urolithiasis guideline on retrograde intrarenal surgery. BJU Int. 2023 Feb;131(2):153-164. doi: 10.1111/bju.15836. Epub 2022 Jul 12.

  PMID: 35733358 BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiaofeng Gao

CONTACT

+86-21-13601600968; gxfdoc@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: July 10, 2025
• Study Start: April 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)