NCT04556396

Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nephrolithiasis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cone beam CT	On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure

Timeline

• Start date: 2020-06-25
• Primary completion: 2021-07-01
• Completion: 2022-05-01
• First posted: 2020-09-21
• Last updated: 2024-06-06
• Results posted: 2024-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study