Kidney StonesPCNLNCT06922006
Feasibility of Radiation-Free Percutaneus Nephrolithotomy for Kidney Stones
An observational study of Kidney Stones, run by University of California, San Diego at 1 site in United States.
Trial summary
The goal of this observational study is to investigate the feasibility of ultrasound-guided percutaneus nephrolithotomy in patients with kidney stones. The main question's it aims to answer are: Does the use of ultrasound in percutaneus nephrolithotomy affect stone free rates, defined by no stone or stone <2mm, on… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Percutaneus nephrolithotomy (PCNL)
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to Jun 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: General population with kidney stones larger than 20mm.
Who may be able to join
- Scheduled percutaneus nephrolithotomy by Dr. Roger Sur between 2022 and 2025 at UCSD Hillcrest.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego, Hillcrest
San Diego, California, 92103
About this study
Official title: Is Radiation Free Percutaneous Nephrolithotomy (PCNL) Feasible: A Prospective Trial
The goal of this observational study is to investigate the feasibility of ultrasound-guided percutaneus nephrolithotomy in patients with kidney stones. The main question's it aims to answer are:
Does the use of ultrasound in percutaneus nephrolithotomy affect stone free rates, defined by no stone or stone <2mm, on follow up visit?
Does the use of ultrasound in percutaneus nephrolithotomy affect complication rates, categorized by Clavien system?
Researchers will compare ultrasound-guided percutaneus nephrolithotomy to traditional nephrolithotomy using fluoroscopy to see if outcomes differ.
Participants will be chosen for any of the above interventions at surgeon's discretion.
Read the detailed description
Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure for removal of kidney stones that has traditionally been done using fluoroscopy for guidance. This study aims to explore if PCNL can be done safely using ultrasound as a replacement for fluoroscopy to decrease radiation exposure.
This study is a prospective cohort comparing subjects that undergoes radiation free and non-radiation free PCNLs performed by a single surgeon at UCSD Health. All cases are evaluated for ultrasound feasibility, and some have to be converted to fluoroscopy at surgeon's discretion. Information about the risks of the procedure including bleeding, infection, incomplete stone removal and injury to the kidney is given to each participant. All surgeries are performed by an experienced urologist with a history of successful ultrasonography interpretation and fluoroscopy is always accessible in the OR in case ultrasonography would not offer good enough imaging quality for the procedure to be completed in a safe and successful manner. The study does not affect the choice of imaging modality used for individual procedures but only looks at characteristics and outcomes of already performed surgeries.
Subjects are selected from the schedule in Epic and divided into three groups, radiation free PCNLs, converted cases and planned PCNLs with fluoroscopy based on information provided in the operative note from each procedure. All subjects that appear on the schedule are included in this study. Data is collected from a US electronic medical record system (Epic), using an online database tool, RedCap. The data consists of 15 cases that have undergone radiation free PCNL, 15 cases that were converted to fluoroscopy, 32 cases that were planned and performed with fluoroscopy. 5 operations had to be aborted. Data is divided into patient demographics (age, gender, ethnicity, BMI, past medical history, anticoagulants), pre-operative data (ASA class, pre-op tubes, laterality, total stone burden, number of stones, stone location, pre-op urine culture, reason for radiation or radiation-free procedure), operative data (imaging modality, access location, number of access attempts, tract dilation size, end of tube case, estimated blood loss, end of case residual stones, total time in operating room (OR), total time under fluoroscopy) and postoperative data (admissions, hospital length of stay, inpatient course, discharge antibiotics, 30 day complications, post-op imaging, post-op stone size, need for additional procedure, post-op creatinine levels and GFR).
- Conditions
- Kidney Stones
- Being tested
- Percutaneus nephrolithotomy (PCNL)
- Keywords
- PCNL
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneus nephrolithotomy (PCNL)Procedure or surgery
Percutaneus nephrolithotomy (PCNL) for removal of large kidney stones
| Study group | Role | What they receive |
|---|---|---|
| Radiation-free PCNL | Cases that were done using ultrasound as the only imaging modality during the entire procedure. Receives: Procedure: Percutaneus nephrolithotomy (PCNL) | |
| Fluoroscopy-guided PCNL | Traditional PCNL's that were planned and performed with fluoroscopy. Receives: Procedure: Percutaneus nephrolithotomy (PCNL) | |
| Converted from radiation-free to fluoroscopy-guided PCNL | Cases that were planned to be done with ultrasound but that ended up having to use fluoroscopy. Receives: Procedure: Percutaneus nephrolithotomy (PCNL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rates
The rate of patients with no stone, or <2mm stone on follow up visit.
Measured: 4-6 weeks after surgery.
Secondary outcomes (12)
Complication rates
Rate of complications defined by Clavien stage 1-5.
Measured: From date of surgery to 30 days post surgery.
ED visits
Rate of patients that had to visit the emergency departent after the surgery.
Measured: From surgery to 30 days after surgery.
Re-admission rates
Rate of patients that had to be re-admitted after the surgery.
Measured: From surgery to 30 days after surgery.
Required additional procedure after PCNL.
Rate of patients that had to be planned for additional procedure after the surgery.
Measured: From surgery to 30 days after surgery.
End of case residual stone prescense.
Rate of patients that had a residual stone visible after the procedure.
Measured: At the end of surgery (In the operating room).
Post-operative stone size
Size of kidney stone on follow up visit after the surgery.
Measured: 4-6 weeks after surgery.
Hospital length of stay.
Amount of days spent in hospital post-operatively.
Measured: From surgery to 4-6 weeks after surgey.
Post-operative outpatient creatinine levels
Creatinine levels.
Measured: From 30 days after surgery to next available creatinine level available in medical records.
Post-operative glomerulal filtration rate (GFR)
Glomerulal filtration rate (GFR) as an indicator of kidney function post-operatively.
Measured: From 30 days after surgery to next available creatinine level available in medical records.
Estimated blood loss
Amount of blood loss the patient had during the surgery.
Measured: From the time of incision to the time of closure.
Total OR time
Time spent in the operating room
Measured: From when the patient enters the operating room until the patient leaves the operating room.
Incision to close time
Time spent operating.
Measured: From the first incision until closure of the last incision.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start26 Mar 2024
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger L Sur, M.D., University of California, San Diego
- Investigators
- Roger L Sur, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922006
- Sponsor's protocol ID
- IRB#180946
- Acronym
- PCNL
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Radiation Free Percutaneous Nephrolithotomy (PCNL) Feasible: A Prospective Trial
- ClinicalTrials.gov ID
- NCT06922006
- Acronym / sponsor ID
- PCNL / IRB#180946
- Conditions
- Kidney Stones
- Keywords
- PCNL
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 10 Apr 2025 (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.
The goal of this observational study is to investigate the feasibility of ultrasound-guided percutaneus nephrolithotomy in patients with kidney stones. The main question's it aims to answer are:
Does the use of ultrasound in percutaneus nephrolithotomy affect stone free rates, defined by no stone or stone <2mm, on follow up visit?
Does the use of ultrasound in percutaneus nephrolithotomy affect complication rates, categorized by Clavien system?
Researchers will compare ultrasound-guided percutaneus nephrolithotomy to traditional nephrolithotomy using fluoroscopy to see if outcomes differ.
Participants will be chosen for any of the above interventions at surgeon's discretion.
Detailed description
Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure for removal of kidney stones that has traditionally been done using fluoroscopy for guidance. This study aims to explore if PCNL can be done safely using ultrasound as a replacement for fluoroscopy to decrease radiation exposure.
This study is a prospective cohort comparing subjects that undergoes radiation free and non-radiation free PCNLs performed by a single surgeon at UCSD Health. All cases are evaluated for ultrasound feasibility, and some have to be converted to fluoroscopy at surgeon's discretion. Information about the risks of the procedure including bleeding, infection, incomplete stone removal and injury to the kidney is given to each participant. All surgeries are performed by an experienced urologist with a history of successful ultrasonography interpretation and fluoroscopy is always accessible in the OR in case ultrasonography would not offer good enough imaging quality for the procedure to be completed in a safe and successful manner. The study does not affect the choice of imaging modality used for individual procedures but only looks at characteristics and outcomes of already performed surgeries.
Subjects are selected from the schedule in Epic and divided into three groups, radiation free PCNLs, converted cases and planned PCNLs with fluoroscopy based on information provided in the operative note from each procedure. All subjects that appear on the schedule are included in this study. Data is collected from a US electronic medical record system (Epic), using an online database tool, RedCap. The data consists of 15 cases that have undergone radiation free PCNL, 15 cases that were converted to fluoroscopy, 32 cases that were planned and performed with fluoroscopy. 5 operations had to be aborted. Data is divided into patient demographics (age, gender, ethnicity, BMI, past medical history, anticoagulants), pre-operative data (ASA class, pre-op tubes, laterality, total stone burden, number of stones, stone location, pre-op urine culture, reason for radiation or radiation-free procedure), operative data (imaging modality, access location, number of access attempts, tract dilation size, end of tube case, estimated blood loss, end of case residual stones, total time in operating room (OR), total time under fluoroscopy) and postoperative data (admissions, hospital length of stay, inpatient course, discharge antibiotics, 30 day complications, post-op imaging, post-op stone size, need for additional procedure, post-op creatinine levels and GFR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiation-free PCNL | – | Procedure: Percutaneus nephrolithotomy (PCNL)Cases that were done using ultrasound as the only imaging modality during the entire procedure. |
| Fluoroscopy-guided PCNL | – | Procedure: Percutaneus nephrolithotomy (PCNL)Traditional PCNL's that were planned and performed with fluoroscopy. |
| Converted from radiation-free to fluoroscopy-guided PCNL | – | Procedure: Percutaneus nephrolithotomy (PCNL)Cases that were planned to be done with ultrasound but that ended up having to use fluoroscopy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General population with kidney stones larger than 20mm.
Key inclusion criteria (1 listed)
- Scheduled percutaneus nephrolithotomy by Dr. Roger Sur between 2022 and 2025 at UCSD Hillcrest.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Percutaneus nephrolithotomy (PCNL)Percutaneus nephrolithotomy (PCNL) for removal of large kidney stones | Procedure or surgery | Converted from radiation-free to fluoroscopy-guided PCNL, Fluoroscopy-guided PCNL, Radiation-free PCNL |
Primary outcome
Stone free rates
Time frame: 4-6 weeks after surgery.
The rate of patients with no stone, or <2mm stone on follow up visit.
12 secondary outcomes
Complication rates
Time frame: From date of surgery to 30 days post surgery.
ED visits
Time frame: From surgery to 30 days after surgery.
Re-admission rates
Time frame: From surgery to 30 days after surgery.
Required additional procedure after PCNL.
Time frame: From surgery to 30 days after surgery.
End of case residual stone prescense.
Time frame: At the end of surgery (In the operating room).
Post-operative stone size
Time frame: 4-6 weeks after surgery.
Hospital length of stay.
Time frame: From surgery to 4-6 weeks after surgey.
Post-operative outpatient creatinine levels
Time frame: From 30 days after surgery to next available creatinine level available in medical records.
Post-operative glomerulal filtration rate (GFR)
Time frame: From 30 days after surgery to next available creatinine level available in medical records.
Estimated blood loss
Time frame: From the time of incision to the time of closure.
Total OR time
Time frame: From when the patient enters the operating room until the patient leaves the operating room.
Incision to close time
Time frame: From the first incision until closure of the last incision.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Roger L Sur, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stones, run by University of California, San Diego at 1 site in United States.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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 rates (time frame: 4-6 weeks after surgery.). 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 10 Apr 2025.