Kidney StoneNCT06507176
Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones
A study testing flexible ureteroscopic lithotripsy and percutaneous nephrolithotomy in people with Kidney Stone, run by The First Hospital of Jilin University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Stone
- What is being tested?
- flexible ureteroscopic lithotripsy and percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2024to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient agrees to participate in the experiment and signs the informed consent, including compliance with the requirements of the experiment
- American Society of Anesthesiologists (ASA) score of 1-2, tolerate surgery
- Age 18-70 years old
- Diagnosed with renal stones via CT scan, with the largest diameter of the stone being 2-4 cm.
Who cannot join
- Excessive obesity, BMI > 28
- Severe urinary tract infection not corrected
- Previous history of kidney transplantation or urinary tract diversion surgery
- Uncorrected bleeding or patients with coagulation dysfunction
- Urinary system congenital malformations, such as polycystic kidney, horseshoe kidney, pelvic ectopic kidney, etc
- Combined with serious heart and lung dysfunction and failure of important organs and cannot tolerate anesthesia or surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Kidney Stone
- Being tested
- flexible ureteroscopic lithotripsy, percutaneous nephrolithotomy
- Keywords
- kidney stone, flexible ureteroscope, percutaneous nephroscopic surgery
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible ureteroscopic lithotripsyProcedure or surgery
This group of patients underwent flexible ureteroscopic lithotripsy.
percutaneous nephrolithotomyProcedure or surgery
This group of patients underwent percutaneous nephrolithotomy.
| Study group | Role | What they receive |
|---|---|---|
| flexible ureteroscopic lithotripsy | Experimental | Not described Receives: Procedure: flexible ureteroscopic lithotripsy |
| percutaneous nephrolithotomy | Active comparator | Not described Receives: Procedure: percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: All patients underwent a 2mm plain CT scan 1 month after surgery to assess final SFR.
Secondary outcomes (4)
Time of operation
Time of operation：From transurethral surgery to indwelling fistula or catheter.
Measured: 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
Measured: 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
Measured: Any surgery-related adverse events that occurred during or less than one month after surgery.
Hospitalization costs
Hospitalization costs: Total costs during hospitalization
Measured: From admission to discharge,assessed up to 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start21 Jul 2024
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Why it stopped: This study was withdrawn prior to enrollment initiation due to the publication of similar studies with the same research objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbo Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507176
- Sponsor's protocol ID
- yanbo wang
- Status last verified
- May 2026
- First submitted
- 4 Jul 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06507176
- Acronym / sponsor ID
- yanbo wang
- Conditions
- Kidney Stone
- Keywords
- kidney stone, flexible ureteroscope, percutaneous nephroscopic surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was withdrawn prior to enrollment initiation due to the publication of similar studies with the same research objectives.
- Enrolment
- 224 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 21 Jul 2024 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flexible ureteroscopic lithotripsy | Experimental | Procedure: flexible ureteroscopic lithotripsy |
| percutaneous nephrolithotomy | Active comparator | Procedure: percutaneous nephrolithotomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient agrees to participate in the experiment and signs the informed consent, including compliance with the requirements of the experiment
- American Society of Anesthesiologists (ASA) score of 1-2, tolerate surgery
- Age 18-70 years old
- Diagnosed with renal stones via CT scan, with the largest diameter of the stone being 2-4 cm.
Key exclusion criteria (6 listed)
- Excessive obesity, BMI > 28
- Severe urinary tract infection not corrected
- Previous history of kidney transplantation or urinary tract diversion surgery
- Uncorrected bleeding or patients with coagulation dysfunction
- Urinary system congenital malformations, such as polycystic kidney, horseshoe kidney, pelvic ectopic kidney, etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flexible ureteroscopic lithotripsyThis group of patients underwent flexible ureteroscopic lithotripsy. | Procedure or surgery | flexible ureteroscopic lithotripsy |
| percutaneous nephrolithotomyThis group of patients underwent percutaneous nephrolithotomy. | Procedure or surgery | percutaneous nephrolithotomy |
Primary outcome
Stone free-rate (SFR)
Time frame: All patients underwent a 2mm plain CT scan 1 month after surgery to assess final 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.
4 secondary outcomes
Time of operation
Time frame: From transurethral surgery to indwelling fistula or catheter, assessed up to 6 hours.
Length of stay
Time frame: From leaving the operating room to discharge,assessed up to 1 month.
Postoperative complication
Time frame: Any surgery-related adverse events that occurred during or less than one month after surgery.
Hospitalization costs
Time frame: From admission to discharge,assessed up to 1 month.
Results and safety
The study was stopped early (reason given: This study was withdrawn prior to enrollment initiation due to the publication of similar studies with the same research objectives.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flexible ureteroscopic lithotripsy and percutaneous nephrolithotomy in people with Kidney Stone, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study was withdrawn prior to enrollment initiation due to the publication of similar studies with the same research objectives.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free-rate (SFR) (time frame: All patients underwent a 2mm plain CT scan 1 month after surgery to assess final SFR.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.