Clinical trial NCT04556396: Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy
Official title: Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrolithiasis
Keywords: percutaneous nephrolithotomy
cone beam CT
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients are assigned to receive intraoperative cone beam CT if enrolled.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: "Second Look" Rate
timeFrame: 90 days
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: 90 days
measure: Surgical Complication Rate
timeFrame: 90 days
measure: "Stone Free" Rate
timeFrame: 90 days
measure: Reobstruction Rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Attending Physician
name: Kristin G Baldea, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pearle MS, Watamull LM, Mullican MA. Sensitivity of noncontrast helical computerized tomography and plain film radiography compared to flexible nephroscopy for detecting residual fragments after percutaneous nephrostolithotomy. J Urol. 1999 Jul;162(1):23-6. doi: 10.1097/00005392-199907000-00006.
citation: Nevo A, Holland R, Schreter E, Gilad R, Baniel J, Cohen A, Lifshitz DA. How Reliable Is the Intraoperative Assessment of Residual Fragments During Percutaneous Nephrolithotomy? A Prospective Study. J Endourol. 2018 Jun;32(6):471-475. doi: 10.1089/end.2018.0005. Epub 2018 Mar 23.
citation: Roy OP, Angle JF, Jenkins AD, Schenkman NS. Cone beam computed tomography for percutaneous nephrolithotomy: initial evaluation of a new technology. J Endourol. 2012 Jul;26(7):814-8. doi: 10.1089/end.2011.0478. Epub 2012 Mar 26.
citation: Pitteloud N, Gamulin A, Barea C, Damet J, Racloz G, Sans-Merce M. Radiation exposure using the O-arm(R) surgical imaging system. Eur Spine J. 2017 Mar;26(3):651-657. doi: 10.1007/s00586-016-4773-0. Epub 2016 Sep 21.
citation: Patel PM, Kandabarow AM, Chuang E, McKenzie K, Druck A, Seffren C, Blanco-Martinez E, Capoccia E, Farooq AV, Branch J, Turk TMT, Baldea KG. Using Intraoperative Portable CT Scan to Minimize Reintervention Rates in Percutaneous Nephrolithotomy: A Prospective Trial. J Endourol. 2022 Oct;36(10):1382-1387. doi: 10.1089/end.2022.0049. Epub 2022 Sep 13.