Flexible Ureteroscopy With Tip-bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2-3cm Renal Stones

NCT06526390 | Completed DMC

• 1 other identifier: MERE2024-001
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief 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 720 patients across 12 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.

Conditions

Urolithiasis; Kidney Stone

Keywords

kidney stone; Flexible ureteroscopy; PCNL

Outcome Measures

Primary Outcomes (1)

• 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 72 hours are defined as stone free.

  Up to 72 hours.

Secondary Outcomes (6)

• Final SFR

  3 months.

• Operative time

  through operation completion, an average of 1 hour

• Duration of hospital stay

  Up to 3 months.

• Further interventions (Second-look PCNL or RIRS or SWL)

  Up to 3 months.

• Complications

  Up to 3 months.

Study Arms (2)

f-URS with S-UAS group

EXPERIMENTAL

f-URS with S-UAS will be performed for patients.

Procedure: f-URS

mini-PCNL group

OTHER

mini-PCNL will be performed for patients.

Procedure: mini-PCNL

Interventions

f-URS PROCEDURE

f-URS with S-UAS

f-URS with S-UAS group

mini-PCNL PROCEDURE

mini-PCNL

mini-PCNL group

Eligibility Criteria

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

You may qualify if:

• Adults aged ≥ 18 years;
• American Society of Anesthesiology score 1-3;
• Renal stones diameter of 2-3 cm confirmed by non contrast-CT;
• Capable of giving written informed consent, including adherence to 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 urinary tract infection;
• Patients with health or other factors that are absolute contraindications to f-URS or mini-PCNL;
• Patients unable to understand or complete trial documentation.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead
• University of Malaya: collaborator
• Ankara University: collaborator
• Saint Petersburg State University Hospital: collaborator
• Fortune Urology Clinic: collaborator
• Guizhou Provincial People's Hospital: collaborator
• Baoshan No.2 People's Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Shengjing Hospital: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator

Study Sites (1)

Wei Zhu

Guangzhou, Guangdong, 510230, China

Location

Related Publications (1)

• Zhu W, Ann Chai C, Ma J, Ilker Gokce M, Gadzhiev N, Kalathia J, Jiang K, Duan X, Cao J, Wu R, Song R, Bai S, Li X, Liu S, Zeng G. Flexible Ureteroscopy with a Tip-bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2-3-cm Renal Stones: Study Protocol for an International, Multicenter, Randomized, Parallel-group, Noninferiority Trial. Eur Urol Open Sci. 2024 Nov 4;70:167-173. doi: 10.1016/j.euros.2024.10.014. eCollection 2024 Dec.

  PMID: 39559532 DERIVED

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients and surgeons cannot be blinded to the allocated trial arm due to the differing nature of the interventions. However, the radiologists assessing the post-operative imaging (CT scans) will be blinded to the intervention. The postoperative clinical assessment will be performed by investigators who are blinded to the surgical procedures and had not been involved in the surgeries. We will perform blinded statistical analyses, in which the individual performing the analyses in unaware the group belonging. The code for group assignment will not be broken until the analyses and interpretation have been completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: August 21, 2024
• Primary Completion: February 20, 2025
• Study Completion: June 4, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)