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Completed

NCT Number: NCT04556396

Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

Percutaneous nephrolithotomy (PCNL) is a first-line treatment for kidney stones >2cm. Frequently, patients require multiple procedures to address their stone burden. The decision to proceed with a second-look procedure is based on follow-up CT imaging, which is obtained postoperatively. In this study, we propose the use of a portable CT scan technology to obtain follow-up imaging while the patient is still under anesthesia for the initial procedure. The goal of this study is to determine whether this allows the surgeon to identify residual fragments and render the patient stone-free within a single anesthetic event.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

Percutaneous nephrolithotomy (PCNL) is considered a first-line management option for kidney stones larger than two centimeters. Unfortunately, because of the large stone burden, up to 70% of these patients are left with residual stone fragments after their initial PCNL. Additionally, an estimated 20% to 60% of such patients ultimately require further interventions due to residual stone fragments. The need for a subsequent procedure is determined by postoperative abdominal computed tomography (CT) imaging, which is routinely performed on the first postoperative day at this institution. The decision to proceed with a second procedure is based on findings from this postoperative CT scan.

Cone-beam CT (CBCT) is a novel portable imaging technique that can allow cross-sectional imaging to be obtained intraoperatively, rather than post-operatively. Incorporating this modality would allow the surgeon to determine whether the procedure should be continued, in the event of residual fragments, or if it can be safely concluded. This would obviate the need for dedicated postoperative CT scans and, more importantly, reduce the need for subsequent procedures and consequently decrease the patient's length of stay.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients >18 years old
  • Scheduled for percutaneous nephrolithotomy with stone fragmentation (laser/ultrasonic/mechanical)
  • For the prospective intervention arm, willingness to consent to participate in the study

Exclusion criteria

  • Patients whose habitus does not allow for the use of the cone beam CT machine
  • Patients whose stones only reside within the mid or distal ureter(s) and thus would not be easily imaged with cone beam CT
  • Patients who have had lithotripsy on their renal unit within the prior 90 days
  • Pregnant patients

Treatment and study plan

Cone beam CT

Diagnostic Test

On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure

Other names: O-arm, Intraoperative CT

Primary outcomes

  1. "Second Look" Rate

    Time frame: 90 days

    The percentage of patients requiring subsequent surgical intervention to remove residual stones

Secondary outcomes

  1. Hospital Length of Stay

    Time frame: 90 days

    The average length of inpatient hospital stay in days

  2. Surgical Complication Rate

    Time frame: 90 days

    The percentage of patients experiencing Clavien-Dindo Grade III-V complications (major) related to the patients' surgery.

  3. "Stone Free" Rate

    Time frame: 90 days

    The percentage of patients who are rendered without residual kidney stone burden after their surgery based on CT scan

  4. Reobstruction Rate

    Time frame: 90 days

    The percentage of patients who presented with symptoms of renal obstruction following their surgery

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 21, 2020
Registry last updated
Jun 6, 2024

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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