NephrolithiasisNCT04556396
Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy
A study testing Cone beam CT in people with Nephrolithiasis, run by Loyola University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Cone beam CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
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.
Read the 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.
- Conditions
- Nephrolithiasis
- Being tested
- Cone beam CT
- Keywords
- percutaneous nephrolithotomy, cone beam CT
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone beam CTDiagnostic test
Also called O-arm, Intraoperative CT
On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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. Receives: Diagnostic Test: Cone beam CT |
| Retrospective arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Second Look" Rate
The percentage of patients requiring subsequent surgical intervention to remove residual stones
Measured: 90 days
Secondary outcomes (4)
Hospital Length of Stay
The average length of inpatient hospital stay in days
Measured: 90 days
Surgical Complication Rate
The percentage of patients experiencing Clavien-Dindo Grade III-V complications (major) related to the patients' surgery.
Measured: 90 days
"Stone Free" Rate
The percentage of patients who are rendered without residual kidney stone burden after their surgery based on CT scan
Measured: 90 days
Reobstruction Rate
The percentage of patients who presented with symptoms of renal obstruction following their surgery
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start25 Jun 2020
- Primary completion1 Jul 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Patients are assigned to receive intraoperative cone beam CT if enrolled.
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Baldea, Loyola University
- Investigators
- Kristin G Baldea, MD, Principal investigator, Attending Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556396
- Sponsor's protocol ID
- 212740
- Status last verified
- Jun 2024
- First submitted
- 15 Sep 2020
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 10379731Nevo 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.
PubMed 29466870Roy 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.
PubMed 22296493Pitteloud 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.
PubMed 27652675Patel 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.
PubMed 35620899
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT04556396
- Acronym / sponsor ID
- 212740
- Conditions
- Nephrolithiasis
- Keywords
- percutaneous nephrolithotomy, cone beam CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are assigned to receive intraoperative cone beam CT if enrolled.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Diagnostic Test: Cone beam CTThis 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. |
| Retrospective arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone beam CTAlso: O-arm, Intraoperative CTOn-table CT scan in the operating room to determine residual kidney stone burden at end of procedure | Diagnostic test | Intervention arm |
Primary outcome
"Second Look" Rate
Time frame: 90 days
The percentage of patients requiring subsequent surgical intervention to remove residual stones
4 secondary outcomes
Hospital Length of Stay
Time frame: 90 days
Surgical Complication Rate
Time frame: 90 days
"Stone Free" Rate
Time frame: 90 days
Reobstruction Rate
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10379731Pearle 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.
- Background: PubMed 29466870Nevo 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.
- Background: PubMed 22296493Roy 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.
- Background: PubMed 27652675Pitteloud 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.
- Derived from this study: PubMed 35620899Patel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin G Baldea, MD principal investigator
Attending Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone beam CT in people with Nephrolithiasis, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Second Look" Rate (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04556396, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.