Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-25

Study Completion Date

2022-05-01

Brief Summary

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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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Detailed Description

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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

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Nephrolithiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Patients are assigned to receive intraoperative cone beam CT if enrolled.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention arm

This arm will receive cone beam CT to perform an abdomen-pelvis CT scan immediately following initial percutaneous nephrolithotomy, before the patient emerges from general anesthesia, to allow the surgeon to determine whether additional work is needed or whether the procedure can be concluded without requiring further imaging or future interventions.

Group Type EXPERIMENTAL

Cone beam CT

Intervention Type DIAGNOSTIC_TEST

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

Retrospective arm

This arm will contain a retrospective cohort of patients who underwent surgery prior to the enrollment of the intervention arm. These patients received the standard of care, namely helical CT postoperative day one.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cone beam CT

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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O-arm Intraoperative CT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No