Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

September 14, 2022 updated by: Kristin Baldea, Loyola University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: Cone beam CT
On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
Other Names:
  • O-arm
  • Intraoperative CT
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Second Look" rate
Time Frame: 90 days
The percentage of patients requiring subsequent surgical intervention to remove residual stones
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: 90 days
The average length of inpatient hospital stay in days
90 days
Surgical complication rate
Time Frame: 90 days
The percentage of patients experiencing Clavien-Dindo Grade III-V complications related to the patients' surgery
90 days
"Stone Free" rate
Time Frame: 90 days
The percentage of patients who are rendered without residual kidney stone burden after their surgery based on CT scan
90 days
Reobstruction rate
Time Frame: 90 days
The percentage of patients who presented with symptoms of renal obstruction following their surgery
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Investigators

  • Principal Investigator: Kristin G Baldea, MD, Attending Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212740

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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