Feasibility of Radiation-Free Percutaneus Nephrolithotomy for Kidney Stones
NCT ID: NCT06922006
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
67 participants
OBSERVATIONAL
2024-03-26
2025-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Radiation-free PCNL
Cases that were done using ultrasound as the only imaging modality during the entire procedure.
Percutaneus nephrolithotomy (PCNL)
Percutaneus nephrolithotomy (PCNL) for removal of large kidney stones
Fluoroscopy-guided PCNL
Traditional PCNL's that were planned and performed with fluoroscopy.
Percutaneus nephrolithotomy (PCNL)
Percutaneus nephrolithotomy (PCNL) for removal of large kidney stones
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.
Percutaneus nephrolithotomy (PCNL)
Percutaneus nephrolithotomy (PCNL) for removal of large kidney stones
Interventions
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Percutaneus nephrolithotomy (PCNL)
Percutaneus nephrolithotomy (PCNL) for removal of large kidney stones
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Roger L Sur, M.D.
Professor of Urology
Principal Investigators
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Roger L Sur, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California San Diego, Hillcrest
San Diego, California, United States
Countries
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Other Identifiers
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IRB#180946
Identifier Type: -
Identifier Source: org_study_id
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