Study of Tomography of Nephrolithiasis Evaluation

Urolithiasis Clinical Trial

— STONE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451931
• Other study ID #: RSB-1002670
• Status: Completed
• Phase: Phase 4
• First received: October 11, 2011
• Last updated: December 2, 2014
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: December 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2776
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Other:
• Point-of-care Ultrasound
Perform ultrasonography in the ED (physician).

Radiation:
• Radiology Ultrasound
Diagnostic ultrasound completed in the radiology department at time 0.

Other:
• Radiology CT
Computed tomography of abdomen completed in the radiology department at time 0.

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Jacobi Medical Center	Bronx	New York
United States	John H. Stroger Jr. Hospital of Cook County	Chicago	Illinois
United States	UCSF at Fresno	Fresno	California
United States	University of Texas Houston Medical Center	Houston	Texas
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University of California, Davis	Sacramento	California
United States	University of Utah	Salt Lake City	Utah
United States	University of California, San Francisco	San Francisco	California
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Cumulative Radiation Exposure		Baseline plus 6 months post-baseline	No
Secondary	ED Length of Stay		Baseline visit excluding hospitalization	No
Secondary	Return Visits to ED or Hospital		6 months post-baseline	No
Secondary	Accuracy for Stones by Arm		Up to 6 month follow-up for stone passage	No