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Study of Tomography of Nephrolithiasis Evaluation (STONE)

Primary Purpose

Urolithiasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Point-of-care Ultrasound
Radiology Ultrasound
Radiology CT
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urolithiasis focused on measuring kidney stone, urolithiasis, urinary tract infection, ultrasound, computed tomography, safety, cost, accuracy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • men or women = or >18 but <76 years of age presenting with acute renal colic
  • Emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones.

Exclusion Criteria:

  • children < 18 years old
  • elderly patients > or = 76 years old
  • pregnancy or planning pregnancy
  • Morbid obesity (>285 pounds in men, >250 pounds in women)
  • patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected).
  • history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)

Sites / Locations

  • UCSF at Fresno
  • University of California, Davis
  • University of California, San Francisco
  • Grady Memorial Hospital
  • John H. Stroger Jr. Hospital of Cook County
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Hennepin County Medical Center
  • Washington University School of Medicine
  • Jacobi Medical Center
  • Oregon Health and Science University
  • Hospital of the University of Pennsylvania
  • Rhode Island Hospital
  • University of Texas Houston Medical Center
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Point-of-care Ultrasound

Radiology Ultrasound

Radiology CT

Arm Description

Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department. Perform ultrasonography in the ED (physician).

Patient with suspected urolithiasis will receive diagnostic ultrasonography in the radiology department. Diagnostic ultrasound completed in the radiology department at time 0.

Patient with suspected urolithiasis will receive computed tomography in the radiology department. Computed tomography of abdomen completed in the radiology department at time 0.

Outcomes

Primary Outcome Measures

High Risk Diagnosis With Complication
Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality.
Cumulative Radiation Exposure

Secondary Outcome Measures

ED Length of Stay
Return Visits to ED or Hospital
Accuracy for Stones by Arm

Full Information

First Posted
October 11, 2011
Last Updated
December 2, 2014
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01451931
Brief Title
Study of Tomography of Nephrolithiasis Evaluation
Acronym
STONE
Official Title
Randomized Controlled Trial of Ultrasound Versus CT (Computed Tomography) for Patients in the Emergency Department With Suspected Renal Colic
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared to computed tomography (CT) for the initial emergency room evaluation of patients with suspected renal colic. The investigators will compare several measures of effectiveness including morbidity related to the patient's underlying disease, or complications related to delayed diagnosis, patient status regarding pain/missed days of work, and utilization of health care resources based on one of three study arms: ultrasound in the Emergency Department, ultrasound in Radiology or CT.
Detailed Description
This is a multi-center, randomized controlled trial of ultrasonography compared with computed tomography (CT) for the evaluation of patients with suspected urolithiasis. The study will be conducted at 15 large urban Emergency Departments (EDs), reflecting geographic, socioeconomic, racial and ethnic diversity, and include academic medical centers as well as safety net hospitals. The patients will be randomized to one of three arms: 1) ultrasound in the Emergency Department (ED), 2) ultrasound in radiology or 3) CT in radiology. The investigators will then collect precise and unbiased data on a comprehensive range of outcomes that will allow assessment of effectiveness, safety, accuracy and cost between patients randomized to one the three groups. Taken together, these measures are intended to provide the basis for a valid comparison of imaging of patients with suspected urolithiasis seen in the ED. The results of this trial could lead to a change in clinical practice that is associated with both improved patient outcomes and reduced cost. Broad stakeholder involvement from within radiology, emergency medicine and several subspecialty communities has been sought to ensure the strategic completion of study aims and to help rapidly disseminate the results of the study into clinical practice. This will create a collaborative network of EDs willing to act as a laboratory for studying the comparative effectiveness of diagnostic testing. As a result, the proposed trial will demonstrate the feasibility of conducting Randomized Control Trials (RCTs) of imaging that incorporates measurements of outcomes that can be expanded to additional imaging tests in the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
kidney stone, urolithiasis, urinary tract infection, ultrasound, computed tomography, safety, cost, accuracy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2776 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Point-of-care Ultrasound
Arm Type
Experimental
Arm Description
Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department. Perform ultrasonography in the ED (physician).
Arm Title
Radiology Ultrasound
Arm Type
Experimental
Arm Description
Patient with suspected urolithiasis will receive diagnostic ultrasonography in the radiology department. Diagnostic ultrasound completed in the radiology department at time 0.
Arm Title
Radiology CT
Arm Type
Experimental
Arm Description
Patient with suspected urolithiasis will receive computed tomography in the radiology department. Computed tomography of abdomen completed in the radiology department at time 0.
Intervention Type
Other
Intervention Name(s)
Point-of-care Ultrasound
Intervention Description
Perform ultrasonography in the ED (physician).
Intervention Type
Radiation
Intervention Name(s)
Radiology Ultrasound
Intervention Description
Diagnostic ultrasound completed in the radiology department at time 0.
Intervention Type
Other
Intervention Name(s)
Radiology CT
Intervention Description
Computed tomography of abdomen completed in the radiology department at time 0.
Primary Outcome Measure Information:
Title
High Risk Diagnosis With Complication
Description
Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality.
Time Frame
30 days from baseline
Title
Cumulative Radiation Exposure
Time Frame
Baseline plus 6 months post-baseline
Secondary Outcome Measure Information:
Title
ED Length of Stay
Time Frame
Baseline visit excluding hospitalization
Title
Return Visits to ED or Hospital
Time Frame
6 months post-baseline
Title
Accuracy for Stones by Arm
Time Frame
Up to 6 month follow-up for stone passage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: men or women = or >18 but <76 years of age presenting with acute renal colic Emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones. Exclusion Criteria: children < 18 years old elderly patients > or = 76 years old pregnancy or planning pregnancy Morbid obesity (>285 pounds in men, >250 pounds in women) patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected). history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Smith-Bindman, MD
Organizational Affiliation
University of California, San Francisco, Department of Radiology and Biomedical Imaging
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clifford Rosen, MD
Organizational Affiliation
Professor of Medicine, Tufts University (Data Safety Monitoring Board Chair)
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF at Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
John H. Stroger Jr. Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of Texas Houston Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

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Study of Tomography of Nephrolithiasis Evaluation

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