Study of Tomography of Nephrolithiasis Evaluation (STONE)

Randomized Controlled Trial of Ultrasound Versus CT (Computed Tomography) for Patients in the Emergency Department With Suspected Renal Colic

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.

Study Overview

• Status: Completed
• Conditions: Urolithiasis
• Intervention / Treatment: Other: Point-of-care Ultrasound; Radiation: Radiology Ultrasound; Other: Radiology 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.

• Study Type: Interventional
• Enrollment (Actual): 2776
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93701
      • UCSF at Fresno
    • Sacramento, California, United States, 95817
      • University of California, Davis
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • John H. Stroger Jr. Hospital of Cook County
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • Missouri
    • St. Louis, Missouri, United States, 63130
      • Washington University School of Medicine
  • New York
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Texas
    • Houston, Texas, United States, 77026
      • University of Texas Houston Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Point-of-care Ultrasound; Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department. Perform ultrasonography in the ED (physician).	Other: Point-of-care Ultrasound; Perform ultrasonography in the ED (physician).
EXPERIMENTAL: Radiology Ultrasound; Patient with suspected urolithiasis will receive diagnostic ultrasonography in the radiology department. Diagnostic ultrasound completed in the radiology department at time 0.	Radiation: Radiology Ultrasound; Diagnostic ultrasound completed in the radiology department at time 0.
EXPERIMENTAL: Radiology CT; Patient with suspected urolithiasis will receive computed tomography in the radiology department. Computed tomography of abdomen completed in the radiology department at time 0.	Other: Radiology CT; Computed tomography of abdomen completed in the radiology department at time 0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days from baseline
Cumulative Radiation Exposure		Baseline plus 6 months post-baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
ED Length of Stay	Baseline visit excluding hospitalization
Return Visits to ED or Hospital	6 months post-baseline
Accuracy for Stones by Arm	Up to 6 month follow-up for stone passage

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Rebecca Smith-Bindman, MD, University of California, San Francisco, Department of Radiology and Biomedical Imaging; Study Chair: Clifford Rosen, MD, Professor of Medicine, Tufts University (Data Safety Monitoring Board Chair)

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: October 11, 2011
• First Submitted That Met QC Criteria: October 13, 2011
• First Posted (ESTIMATE): October 14, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: safety; ultrasound; accuracy; computed tomography; urolithiasis; urinary tract infection; cost; kidney stone
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: RSB-1002670