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NCT Number: NCT06922006

Feasibility of Radiation-Free Percutaneus Nephrolithotomy for Kidney Stones

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Scheduled percutaneus nephrolithotomy by Dr. Roger Sur between 2022 and 2025 at UCSD Hillcrest.

Exclusion criteria

-

Treatment and study plan

Percutaneus nephrolithotomy (PCNL)

Procedure

Percutaneus nephrolithotomy (PCNL) for removal of large kidney stones

Primary outcomes

  1. Stone free rates

    Time frame: 4-6 weeks after surgery.

    The rate of patients with no stone, or <2mm stone on follow up visit.

Secondary outcomes

  1. Complication rates

    Time frame: From date of surgery to 30 days post surgery.

    Rate of complications defined by Clavien stage 1-5.

  2. ED visits

    Time frame: From surgery to 30 days after surgery.

    Rate of patients that had to visit the emergency departent after the surgery.

  3. Re-admission rates

    Time frame: From surgery to 30 days after surgery.

    Rate of patients that had to be re-admitted after the surgery.

  4. Required additional procedure after PCNL.

    Time frame: From surgery to 30 days after surgery.

    Rate of patients that had to be planned for additional procedure after the surgery.

  5. End of case residual stone prescense.

    Time frame: At the end of surgery (In the operating room).

    Rate of patients that had a residual stone visible after the procedure.

  6. Post-operative stone size

    Time frame: 4-6 weeks after surgery.

    Size of kidney stone on follow up visit after the surgery.

  7. Hospital length of stay.

    Time frame: From surgery to 4-6 weeks after surgey.

    Amount of days spent in hospital post-operatively.

  8. Post-operative outpatient creatinine levels

    Time frame: From 30 days after surgery to next available creatinine level available in medical records.

    Creatinine levels.

  9. Post-operative glomerulal filtration rate (GFR)

    Time frame: From 30 days after surgery to next available creatinine level available in medical records.

    Glomerulal filtration rate (GFR) as an indicator of kidney function post-operatively.

  10. Estimated blood loss

    Time frame: From the time of incision to the time of closure.

    Amount of blood loss the patient had during the surgery.

  11. Total OR time

    Time frame: From when the patient enters the operating room until the patient leaves the operating room.

    Time spent in the operating room

  12. Incision to close time

    Time frame: From the first incision until closure of the last incision.

    Time spent operating.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Is Radiation Free Percutaneous Nephrolithotomy (PCNL) Feasible: A Prospective Trial

Acronym: PCNL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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