Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

Nephrolithiasis Clinical Trial

Official title:

Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556396
• Other study ID #: 212740
• Status: Completed
• Phase: N/A
• Start date: June 25, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2024
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: May 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis

Intervention

Diagnostic Test:
• Cone beam CT
On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Second Look" Rate	The percentage of patients requiring subsequent surgical intervention to remove residual stones	90 days
Secondary	Hospital Length of Stay	The average length of inpatient hospital stay in days	90 days
Secondary	Surgical Complication Rate	The percentage of patients experiencing Clavien-Dindo Grade III-V complications (major) related to the patients' surgery.	90 days
Secondary	"Stone Free" Rate	The percentage of patients who are rendered without residual kidney stone burden after their surgery based on CT scan	90 days
Secondary	Reobstruction Rate	The percentage of patients who presented with symptoms of renal obstruction following their surgery	90 days