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Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04556396
Enrollment
234
Registered
2020-09-21
Start date
2020-06-25
Completion date
2022-05-01
Last updated
2024-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrolithiasis

Keywords

percutaneous nephrolithotomy, cone beam CT

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.

Interventions

DIAGNOSTIC_TESTCone beam CT

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

Sponsors

Loyola University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Second Look Rate90 daysThe percentage of patients requiring subsequent surgical intervention to remove residual stones

Secondary

MeasureTime frameDescription
Hospital Length of Stay90 daysThe average length of inpatient hospital stay in days
Surgical Complication Rate90 daysThe percentage of patients experiencing Clavien-Dindo Grade III-V complications (major) related to the patients' surgery.
Stone Free Rate90 daysThe percentage of patients who are rendered without residual kidney stone burden after their surgery based on CT scan
Reobstruction Rate90 daysThe percentage of patients who presented with symptoms of renal obstruction following their surgery

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Cone beam CT: On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
60
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.
174
Total234

Baseline characteristics

CharacteristicTotalRetrospective ArmIntervention Arm
Age, Continuous57.9 years
STANDARD_DEVIATION 15.2
57 years
STANDARD_DEVIATION 15
59 years
STANDARD_DEVIATION 15
Race/Ethnicity, Customized
Asian
9 Participants5 Participants4 Participants
Race/Ethnicity, Customized
Black
17 Participants12 Participants5 Participants
Race/Ethnicity, Customized
Ethnicity
Hispanic
27 Participants21 Participants6 Participants
Race/Ethnicity, Customized
Ethnicity
Non-Hispanic
205 Participants151 Participants54 Participants
Race/Ethnicity, Customized
Ethnicity
Unknown
2 Participants2 Participants0 Participants
Race/Ethnicity, Customized
Other
14 Participants11 Participants3 Participants
Race/Ethnicity, Customized
Unknown
3 Participants1 Participants2 Participants
Race/Ethnicity, Customized
White
191 Participants145 Participants46 Participants
Region of Enrollment
United States
234 participants174 participants60 participants
Sex: Female, Male
Female
125 Participants88 Participants37 Participants
Sex: Female, Male
Male
109 Participants86 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 600 / 174
other
Total, other adverse events
0 / 600 / 174
serious
Total, serious adverse events
0 / 600 / 174

Outcome results

Primary

Second Look Rate

The percentage of patients requiring subsequent surgical intervention to remove residual stones

Time frame: 90 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention ArmSecond Look RateReintervention4 Participants
Intervention ArmSecond Look RateNo Reintervention56 Participants
Retrospective ArmSecond Look RateReintervention56 Participants
Retrospective ArmSecond Look RateNo Reintervention118 Participants
p-value: <0.0195% CI: [0.1, 0.4]Chi-squared
Secondary

Hospital Length of Stay

The average length of inpatient hospital stay in days

Time frame: 90 days

ArmMeasureValue (MEAN)Dispersion
Intervention ArmHospital Length of Stay2.3 DaysStandard Deviation 1.5
Retrospective ArmHospital Length of Stay3.5 DaysStandard Deviation 2.5
Secondary

Reobstruction Rate

The percentage of patients who presented with symptoms of renal obstruction following their surgery

Time frame: 90 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention ArmReobstruction Rate11 Participants
Retrospective ArmReobstruction Rate26 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention ArmStone Free Rate49 Participants
Retrospective ArmStone Free Rate63 Participants
Secondary

Surgical Complication Rate

The percentage of patients experiencing Clavien-Dindo Grade III-V complications (major) related to the patients' surgery.

Time frame: 90 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention ArmSurgical Complication Rate2 Participants
Retrospective ArmSurgical Complication Rate17 Participants

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026