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TerminatedNCT06507176Updated May 8, 2026

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

An interventional study of flexible ureteroscopic lithotripsy and percutaneous nephrolithotomy in Kidney Stone, sponsored by The First Hospital of Jilin University. Terminated at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by The First Hospital of Jilin University · Not applicable, Interventional, and Treatment

Why this study was terminated
This study was withdrawn prior to enrollment initiation due to the publication of similar studies with the same research objectives.
Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

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.

02

Conditions studied

  • Kidney Stone

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Keywords

  • kidney stone
  • flexible ureteroscope
  • percutaneous nephroscopic surgery
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In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's enrollment of 224 is above the median of 90 across 461 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

The First Hospital of Jilin University is the lead sponsor of 181 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
224 participants (actual)

Study arms

  • Experimental
    flexible ureteroscopic lithotripsy

    Procedure: flexible ureteroscopic lithotripsy

  • Active comparator
    percutaneous nephrolithotomy

    Procedure: percutaneous nephrolithotomy

Interventions

  • Procedureflexible ureteroscopic lithotripsy

    This group of patients underwent flexible ureteroscopic lithotripsy.

  • Procedurepercutaneous nephrolithotomy

    This group of patients underwent percutaneous nephrolithotomy.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: All patients underwent a 2mm plain CT scan 1 month after surgery to assess final SFR.

Secondary outcomes

  1. Time of operation

    Time of operation:From transurethral surgery to indwelling fistula or catheter.

    Time frame: From transurethral surgery to indwelling fistula or catheter, assessed up to 6 hours.

  2. Length of stay

    Length of stay: from leaving the operating room to discharge

    Time frame: From leaving the operating room to discharge,assessed up to 1 month.

  3. Postoperative complication

    Postoperative complication:Any surgery-related adverse events that occurred during or less than one month after surgery

    Time frame: Any surgery-related adverse events that occurred during or less than one month after surgery.

  4. Hospitalization costs

    Hospitalization costs: Total costs during hospitalization

    Time frame: From admission to discharge,assessed up to 1 month.

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Study locations

1 site
  • Yanbowang
    Ch’ang-ch’un, Jilin 130000, China
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References and documents

Individual participant data

Plan to share: Yes — There is a plan to make IPD and related data dictionaries available.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06507176
Lead sponsor
The First Hospital of Jilin University
Responsible party
Yanbo Wang (Clinical Professor, The First Hospital of Jilin University) — Principal investigator
First posted
Jul 18, 2024
Start date
Jul 21, 2024
Primary completion
Apr 15, 2026
Completion
Apr 15, 2026
Last update
May 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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