Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

NCT04556396 | Completed Results FDA Device

• 1 other identifier: 212740
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrolithiasis

Keywords

percutaneous nephrolithotomy; cone beam CT

Outcome Measures

Primary Outcomes (1)

• "Second Look" Rate

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

  90 days

Secondary Outcomes (4)

• Hospital Length of Stay

  90 days

• Surgical Complication Rate

  90 days

• "Stone Free" Rate

  90 days

• Reobstruction Rate

  90 days

Study Arms (2)

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.

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.

Interventions

Cone beam CT DIAGNOSTIC_TEST

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

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (5)

• 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.

  PMID: 10379731 BACKGROUND

• 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.

  PMID: 29466870 BACKGROUND

• 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.

  PMID: 22296493 BACKGROUND

• 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.

  PMID: 27652675 BACKGROUND

• 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.

  PMID: 35620899 DERIVED

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Tomography, X-Ray; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Results Point of Contact

• Title: Kristin Baldea
• Organization: Loyola University Medical Center

kbaldea@lumc.edu

708-216-9000

Study Officials

• Kristin G Baldea, MD

  Attending Physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor Of Urology

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

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: June 25, 2020
• Primary Completion: July 1, 2021
• Study Completion: May 1, 2022
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)