Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones

Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones: a Multicenter Prospective Randomized Controlled Trial

Urolithiasis is a common disease in urology. With the continuous progress of science and technology, the treatment of kidney lithiasis has undergone revolutionary changes, and the previously commonly used open surgical lithotomy method has been gradually eliminated, and replaced with less traumatic treatment methods. Percutaneous nephroscopy can theoretically treat the vast majority of kidney stones, especially in the treatment of kidney stones > 2 cm, it is widely used. With the development of ureteroscopy technology, the adaptation of ureteroscopy for the treatment of kidney stones has been expanding, and people have gradually paid attention to it with less damage and higher safety. This study aims to evaluate whether the efficacy and safety of soft ureteral lithotomy in the treatment of 2-4cm kidney stones is equal to that of percutaneous nephrolithotomy through prospective randomized controlled clinical trials, so as to provide more choices for physicians and patients, and provide theoretical basis for the standardization of clinical practice and the rationality of treatment.

Study Overview

• Status: Terminated
• Conditions: Kidney Stone
• Intervention / Treatment: Procedure: flexible ureteroscopic lithotripsy; Procedure: percutaneous nephrolithotomy

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Ch’ang-ch’un, Jilin, China, 130000
      • Yanbowang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The patient agrees to participate in the experiment and signs the informed consent, including compliance with the requirements of the experiment
2. American Society of Anesthesiologists (ASA) score of 1-2, tolerate surgery
3. Age 18-70 years old
4. Diagnosed with renal stones via CT scan, with the largest diameter of the stone being 2-4 cm.

Exclusion Criteria:

1. Excessive obesity, BMI > 28
2. Severe urinary tract infection not corrected
3. Previous history of kidney transplantation or urinary tract diversion surgery
4. Uncorrected bleeding or patients with coagulation dysfunction
5. Urinary system congenital malformations, such as polycystic kidney, horseshoe kidney, pelvic ectopic kidney, etc
6. Combined with serious heart and lung dysfunction and failure of important organs and cannot tolerate anesthesia or surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: flexible ureteroscopic lithotripsy	Procedure: flexible ureteroscopic lithotripsy; This group of patients underwent flexible ureteroscopic lithotripsy.
Active Comparator: percutaneous nephrolithotomy	Procedure: percutaneous nephrolithotomy; This group of patients underwent percutaneous nephrolithotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free-rate (SFR)	Stone-free status is defined as the absence of any residual stone fragments or the presence of clinically meaningless residual stone fragments in the kidney, defined as ≤4mm, asymptomatic, non-obstructive, and non-infectious stone particles.	All patients underwent a 2mm plain CT scan 1 month after surgery to assess final SFR.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of operation	Time of operation：From transurethral surgery to indwelling fistula or catheter.	From transurethral surgery to indwelling fistula or catheter, assessed up to 6 hours.
Length of stay	Length of stay: from leaving the operating room to discharge	From leaving the operating room to discharge,assessed up to 1 month.
Postoperative complication	Postoperative complication：Any surgery-related adverse events that occurred during or less than one month after surgery	Any surgery-related adverse events that occurred during or less than one month after surgery.
Hospitalization costs	Hospitalization costs: Total costs during hospitalization	From admission to discharge,assessed up to 1 month.

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2024
• Primary Completion (Actual): April 15, 2026
• Study Completion (Actual): April 15, 2026

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: kidney stone; flexible ureteroscope; percutaneous nephroscopic surgery
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Kidney Calculi; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Endoscopy; Urologic Surgical Procedures; Urogenital Surgical Procedures; Laparoscopy; Nephrolithotomy, Percutaneous
• Other Study ID Numbers: yanbo wang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There is a plan to make IPD and related data dictionaries available.
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No