An interventional study of Cone beam CT in Nephrolithiasis, sponsored by Loyola University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by Loyola University · Not applicable, Interventional, and Treatment
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.
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.
460 studies on the registry are indexed under Nephrolithiasis; 108 are open to participants now.
This study's enrollment of 234 is above the median of 92 across 361 interventional studies indexed under Nephrolithiasis.
Browse Nephrolithiasis studies →Loyola University is the lead sponsor of 132 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
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Exclusion Criteria:
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.
Diagnostic Test: Cone beam CT
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.
On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
Also known as: O-arm, Intraoperative CT
"Second Look" Rate
The percentage of patients requiring subsequent surgical intervention to remove residual stones
Time frame: 90 days
Hospital Length of Stay
The average length of inpatient hospital stay in days
Time frame: 90 days
Surgical Complication Rate
The percentage of patients experiencing Clavien-Dindo Grade III-V complications (major) related to the patients' surgery.
Time frame: 90 days
"Stone Free" Rate
The percentage of patients who are rendered without residual kidney stone burden after their surgery based on CT scan
Time frame: 90 days
Reobstruction Rate
The percentage of patients who presented with symptoms of renal obstruction following their surgery
Time frame: 90 days
| Milestone | Intervention Arm | Retrospective Arm |
|---|---|---|
| Started | 60 | 174 |
| Completed | 60 | 174 |
| Not completed | 0 | 0 |
The percentage of patients requiring subsequent surgical intervention to remove residual stones
| Participants | Intervention Arm | Retrospective Arm |
|---|---|---|
| Reintervention | 4 | 56 |
| No Reintervention | 56 | 118 |
The average length of inpatient hospital stay in days
| Days | Intervention Arm | Retrospective Arm |
|---|---|---|
| Hospital Length of Stay | 2.3 ± 1.5 | 3.5 ± 2.5 |
The percentage of patients experiencing Clavien-Dindo Grade III-V complications (major) related to the patients' surgery.
| Participants | Intervention Arm | Retrospective Arm |
|---|---|---|
| Surgical Complication Rate | 2 | 17 |
The percentage of patients who are rendered without residual kidney stone burden after their surgery based on CT scan
| Participants | Intervention Arm | Retrospective Arm |
|---|---|---|
| "Stone Free" Rate | 49 | 63 |
The percentage of patients who presented with symptoms of renal obstruction following their surgery
| Participants | Intervention Arm | Retrospective Arm |
|---|---|---|
| Reobstruction Rate | 11 | 26 |
Collected over Time frame used to assess outcomes and adverse events was 90 days post index procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Arm | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Retrospective Arm | 0/174 (0%) | 0/174 (0%) | 0/174 (0%) |
| Age, Continuous(years) | Intervention Arm | Retrospective Arm | Total |
|---|---|---|---|
| Mean | 59 ± 15 | 57 ± 15 | 57.9 ± 15.2 |
| Sex: Female, Male(Participants) | Intervention Arm | Retrospective Arm | Total |
|---|---|---|---|
| Female | 37 | 88 | 125 |
| Male | 23 | 86 | 109 |
| Race/Ethnicity, Customized(Participants) | Intervention Arm | Retrospective Arm | Total |
|---|---|---|---|
| White | 46 | 145 | 191 |
| Black | 5 | 12 | 17 |
| Other | 3 | 11 | 14 |
| Unknown | 2 | 1 | 3 |
| Asian | 4 | 5 | 9 |
| Race/Ethnicity, Customized(Participants) | Intervention Arm | Retrospective Arm | Total |
|---|---|---|---|
| Ethnicity — Hispanic | 6 | 21 | 27 |
| Ethnicity — Non-Hispanic | 54 | 151 | 205 |
| Ethnicity — Unknown | 0 | 2 | 2 |
| Region of Enrollment(participants) | Intervention Arm | Retrospective Arm | Total |
|---|---|---|---|
| United States | 60 | 174 | 234 |
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Loyola University