N/A
N=234
Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy
Nephrolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT04556396 ↗Enrolled (actual)
234
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: "Second Look" Rate — 4; 56; 56; 118 Participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cone beam CT (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Loyola University
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY "Second Look" Rate |
4; 56; 56; 118 | <0.01 sig |
| SECONDARY Hospital Length of Stay |
2.3; 3.5 | — |
| SECONDARY Surgical Complication Rate |
2; 17 | — |
| SECONDARY "Stone Free" Rate |
49; 63 | — |
| SECONDARY Reobstruction Rate |
11; 26 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04556396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.