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Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient Management (CEUS)

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ClinicalTrials.gov Identifier: NCT03058614
Recruitment Status : Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : April 22, 2019
Sponsor:
Collaborators:
Oregon Health and Science University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Thomas Chi, MD, University of California, San Francisco

Brief Summary:
This study will be a randomized controlled study comparing the use of two clinical management strategies in nephrostomy tube management following percutaneous nephrolithotomy (PCNL). The first strategy entails using contrast-enhanced ultrasound (CEUS) to evaluate the renal collecting system (1). This is a new imaging approach applying ultrasound machines with special software in combination with intraluminal ultrasound contrast agent (Lumason) injection, which is an FDA-approved ultrasound contrast agent (2). The second strategy is a nephrostomy tube capping trial combined with low dose non-contrast computed tomography (CT) scan, one of the most frequently utilized clinical management strategies currently used in clinical practice (3).

Condition or disease Intervention/treatment Phase
Ultrasonography Nephrolithiasis Drug: CEUS Diagnostic Test: Non-contrast CT scan Diagnostic Test: Capping trial Phase 2

Detailed Description:

This is a multi-center, randomized controlled study comparing the use of CEUS to CT scan plus capping trial immediately following PCNL. A total recruitment target of 1,046 subjects is planned and participants will be randomized into one of the two study arms.

  1. Contrast-enhanced ultrasound (CEUS) arm: On postoperative day 1 (unless not clinically indicated), each subject will undergo CEUS with an administration of Lumason via their pre-placed nephrostomy tube.
  2. Non-contrast CT scan plus capping trial arm: On postoperative day 1 (unless not clinically indicated), subjects' pre-placed nephrostomy tube will be capped and they will undergo a low dose non-contrast abdominal CT scan.

Subsequently, nephrostomy tubes will be managed based on the results from these studies by the treating surgeon.

Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

The following investigational regimen will be used only in the CEUS arm:

Experimental Investigation: Lumason at a 2 mL single dose, repeatable once at the time of imaging as needed.

Subjects will be exposed to the randomization schema for 1 day during which they will undergo one of the two diagnostic imaging pathways. After that imaging study is complete, clinical care will proceed as per norm. Clinical and imaging data will be prospectively collected from the time of initial presentation until 6 months after surgery. The total duration of the study is expected to be 5 years to reach target accrual. Therefore, the investigators anticipate that the total duration of this study will be 4 years and 6 months for patient recruitment with the final 6 months used for collecting follow up data.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1046 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control study
Masking: Double (Care Provider, Investigator)
Masking Description: The surgical team will be blinded to the randomization outcome of the patient until the day after surgery so as to minimize any bias introduced into their preoperative counseling. After that point, treatment teams will no longer be blinded to randomization.
Primary Purpose: Diagnostic
Official Title: Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CEUS arm
On postoperative day 1 (unless not clinically indicated), each subject will undergo CEUS with an administration of Lumason via their pre-placed nephrostomy tube.
Drug: CEUS
In subjects randomized into the CEUS arm, 2 mL of Lumason will be injected as a single dose via a nephrostomy tube at the time of postoperative renal ultrasound, following by 5 mL of normal saline flush. Subjects will be given up to one additional dose injected in the same fashion as indicated during the imaging study to confirm opacification of the ureter.
Other Name: Contrast-enhanced ultrasound, CEUS nephrostogram

Active Comparator: CT scan plus capping trial arm
On postoperative day 1 (unless not clinically indicated), subjects' pre-placed nephrostomy tube will be capped and they will undergo a low dose non-contrast abdominal CT scan.
Diagnostic Test: Non-contrast CT scan
The CT scan performed in this study arm is regularly performed to evaluate the kidney and look for residual stones after surgery both at UCSF and around the world. It does not require contrast injection, so risks from contrast allergy or any injection are absent. A low dose protocol will be used, and therefore, subjects will be exposed to a very small amount of ionizing radiation as low as 1-2 mSv if randomized into this arm.
Other Name: NCCT

Diagnostic Test: Capping trial
Subjects who are randomized into this study arm will undergo both nephrostomy tube capping and a low dose non-contrast CT scan on the first day after surgery. Successfully passing a capping trial is defined as the absence of fever, worsened flank pain, and leakage around the nephrostomy tube within 4 hours after capping the tube.




Primary Outcome Measures :
  1. Radiation exposure dose [ Time Frame: 6 months following surgery ]
    For radiation exposure dose measurement in this study, the investigators will use dose metrics obtained from the Digital Imaging and Communications within the scanners or Picture Arching and Communication system (PACS).


Secondary Outcome Measures :
  1. Rate of adverse clinical events [ Time Frame: 6 months following surgery ]
    Defined as postoperative complications and any unplanned surgery related to the patient's kidney stone



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18 years or older.
  • Renal and/or ureteral stone of any size diagnosed either by ultrasound or CT scan and requiring surgical treatment with percutaneous removal (PCNL).

Exclusion Criteria:

  • A second stage PCNL is planned or expected after surgery, entailing that postoperative tube management is pre-determined.
  • Subjects with serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.
  • Subjects with a history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason
  • Pregnancy, which is a contraindication to both CT scan and ultrasound contrast injection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058614


Contacts
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Contact: Thomas Chi, MD 415-353-2200 tom.chi@ucsf.edu
Contact: Victoria R. Hogue 415-502-2603 Victoria.Hogue@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Oregon Health and Science University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Thomas Chi, MD UCSF Department of Urology

Publications:
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Responsible Party: Thomas Chi, MD, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03058614     History of Changes
Other Study ID Numbers: 17-21497
R21DK109433 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Chi, MD, University of California, San Francisco:
Contrast-enhanced ultrasound
Percutaneous nephrolithotomy
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical