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Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

Primary Purpose

Nephrolithiasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cone beam CT
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis focused on measuring percutaneous nephrolithotomy, cone beam CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Retrospective arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

"Second Look" rate
The percentage of patients requiring subsequent surgical intervention to remove residual stones

Secondary Outcome Measures

Hospital length of stay
The average length of inpatient hospital stay in days
Surgical complication rate
The percentage of patients experiencing Clavien-Dindo Grade III-V complications related to the patients' surgery
"Stone Free" rate
The percentage of patients who are rendered without residual kidney stone burden after their surgery based on CT scan
Reobstruction rate
The percentage of patients who presented with symptoms of renal obstruction following their surgery

Full Information

First Posted
September 15, 2020
Last Updated
September 14, 2022
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT04556396
Brief Title
Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy
Official Title
Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis
Keywords
percutaneous nephrolithotomy, cone beam CT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients are assigned to receive intraoperative cone beam CT if enrolled.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Retrospective arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cone beam CT
Other Intervention Name(s)
O-arm, Intraoperative CT
Intervention Description
On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
Primary Outcome Measure Information:
Title
"Second Look" rate
Description
The percentage of patients requiring subsequent surgical intervention to remove residual stones
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Hospital length of stay
Description
The average length of inpatient hospital stay in days
Time Frame
90 days
Title
Surgical complication rate
Description
The percentage of patients experiencing Clavien-Dindo Grade III-V complications related to the patients' surgery
Time Frame
90 days
Title
"Stone Free" rate
Description
The percentage of patients who are rendered without residual kidney stone burden after their surgery based on CT scan
Time Frame
90 days
Title
Reobstruction rate
Description
The percentage of patients who presented with symptoms of renal obstruction following their surgery
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients >18 years old Scheduled for percutaneous nephrolithotomy with stone fragmentation (laser/ultrasonic/mechanical) For the prospective intervention arm, willingness to consent to participate in the study Exclusion Criteria: Patients whose habitus does not allow for the use of the cone beam CT machine Patients whose stones only reside within the mid or distal ureter(s) and thus would not be easily imaged with cone beam CT Patients who have had lithotripsy on their renal unit within the prior 90 days Pregnant patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin G Baldea, MD
Organizational Affiliation
Attending Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10379731
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.
Results Reference
background
PubMed Identifier
29466870
Citation
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.
Results Reference
background
PubMed Identifier
22296493
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.
Results Reference
background
PubMed Identifier
27652675
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.
Results Reference
background
PubMed Identifier
35620899
Citation
Patel PM, Kandabarow AM, Chuang E, McKenzie K, Druck A, Seffren C, Blanco-Martinez E, Capoccia E, Farooq AV, Branch J, Turk TMT, Baldea KG. Using Intraoperative Portable CT Scan to Minimize Reintervention Rates in Percutaneous Nephrolithotomy: A Prospective Trial. J Endourol. 2022 Oct;36(10):1382-1387. doi: 10.1089/end.2022.0049. Epub 2022 Sep 13.
Results Reference
derived

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Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

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