Back Pain Clinical Trial
— ProspectiveOfficial title:
Validation of a Decision Rule to Limit CT Scanning in Suspected Renal Colic
NCT number | NCT01352676 |
Other study ID # | 1104008278 |
Secondary ID | HS018322 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2011 |
Est. completion date | March 2014 |
Verified date | March 2020 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Computed tomography (CT) scanning is overused, expensive, and causes cancer. CT scan utilization in the U.S. has increased from an estimated 3 million CTs in 1980 to 62 million per year in 2007. From 2000 through 2006, Medicare spending on imaging more than doubled to $13.8 billion with advanced imaging such as CT scanning largely responsible. CT represents only 11% of radiologic examinations but is responsible for two-thirds of the ionizing radiation associated with medical imaging in the U.S. Recent estimates suggest that there will be 12.5 cancer deaths for every 10,000 CT scans. Renal colic is a common, non-life-threatening condition for which CT is overused. As many as 12% of people will have a kidney stone in their lifetime, and more than one million per year will present to the emergency department (ED). CT is now a first line test for renal colic, and is very accurate. However, 98% of kidney stones 5mm or smaller will pass spontaneously, and CT rarely alters management. A decision rule is needed to determine which patients with suspected renal colic require CT. While the signs and symptoms of renal colic have been shown to be predictable, no rule has yet been rigorously derived or validated to guide CT imaging in renal colic. A subset of patients with suspected renal colic may have a more serious diagnosis or a kidney stone that will require intervention; however the investigators maintain that clinical criteria, point of care ultrasound and plain radiography (when appropriate), will provide a more comparatively effective and safer approach by appropriately limiting imaging.
Status | Completed |
Enrollment | 635 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who present to the adult YNHH ED and Shoreline Medical Center SMC ED who are - 18 years or older, - renal colic is suspected upon presentation to the ED suggested by flank pain, back pain, abdominal pain, and/or hematuria, and - the physician intends to order a CT FPP study for suspicion of a kidney stone. Members of all ethnic and racial groups are eligible. Exclusion Criteria: - Patients will be excluded for any one of the following reasons: patients that are - pregnant - prisoners - unable or unwilling to consent (including non-English speaking) and - with a history or physical evidence of recent trauma. |
Country | Name | City | State |
---|---|---|---|
United States | Shoreline Medical Center | Guilford | Connecticut |
United States | Yale University, Emergency Department | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | Agency for Healthcare Research and Quality (AHRQ) |
United States,
Brenner D, Elliston C, Hall E, Berdon W. Estimated risks of radiation-induced fatal cancer from pediatric CT. AJR Am J Roentgenol. 2001 Feb;176(2):289-96. — View Citation
Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. Review. — View Citation
Broder J, Bowen J, Lohr J, Babcock A, Yoon J. Cumulative CT exposures in emergency department patients evaluated for suspected renal colic. J Emerg Med. 2007 Aug;33(2):161-8. Epub 2007 Jun 5. — View Citation
Catalano O, Nunziata A, Altei F, Siani A. Suspected ureteral colic: primary helical CT versus selective helical CT after unenhanced radiography and sonography. AJR Am J Roentgenol. 2002 Feb;178(2):379-87. — View Citation
Elton TJ, Roth CS, Berquist TH, Silverstein MD. A clinical prediction rule for the diagnosis of ureteral calculi in emergency departments. J Gen Intern Med. 1993 Feb;8(2):57-62. — View Citation
Fritzsche P, Amis ES Jr, Bigongiari LR, Bluth EI, Bush WH Jr, Choyke PL, Holder L, Newhouse JH, Sandler CM, Segal AJ, Resnick MI, Rutsky EA. Acute onset flank pain, suspicion of stone disease. American College of Radiology. ACR Appropriateness Criteria. Radiology. 2000 Jun;215 Suppl:683-6. — View Citation
Gottlieb RH, La TC, Erturk EN, Sotack JL, Voci SL, Holloway RG, Syed L, Mikityansky I, Tirkes AT, Elmarzouky R, Zwemer FL, Joseph JV, Davis D, DiGrazio WJ, Messing EM. CT in detecting urinary tract calculi: influence on patient imaging and clinical outcomes. Radiology. 2002 Nov;225(2):441-9. — View Citation
Jindal G, Ramchandani P. Acute flank pain secondary to urolithiasis: radiologic evaluation and alternate diagnoses. Radiol Clin North Am. 2007 May;45(3):395-410, vii. Review. — View Citation
Kalra MK, Maher MM, Toth TL, Hamberg LM, Blake MA, Shepard JA, Saini S. Strategies for CT radiation dose optimization. Radiology. 2004 Mar;230(3):619-28. Epub 2004 Jan 22. Review. — View Citation
Medicare Part B Imaging Services. General Accounting Office. Washington D.C., 2008.
Mettler FA Jr, Wiest PW, Locken JA, Kelsey CA. CT scanning: patterns of use and dose. J Radiol Prot. 2000 Dec;20(4):353-9. — View Citation
Ripollés T, Agramunt M, Errando J, Martínez MJ, Coronel B, Morales M. Suspected ureteral colic: plain film and sonography vs unenhanced helical CT. A prospective study in 66 patients. Eur Radiol. 2004 Jan;14(1):129-36. Epub 2003 Jun 19. — View Citation
Ripollés T, Errando J, Agramunt M, Martínez MJ. Ureteral colic: US versus CT. Abdom Imaging. 2004 Mar-Apr;29(2):263-6. Review. — View Citation
Teichman JM. Clinical practice. Acute renal colic from ureteral calculus. N Engl J Med. 2004 Feb 12;350(7):684-93. Review. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ultra Low Dose vs Regular CT Scans | both the CT results and the follow-up documentation will be reviewed by two separate MD observers who are blinded to both the predictor variables and the outcome of the decision rule. CT results will be categorized as defined above, and intervention as defined above will either be considered present (immediate or delayed) or absent based on follow-up documentation. In the case where there is a discrepancy in the categorization of CT or intervention, a third reviewer will be used as a tie-breaker, with discussion amongst all parties to reach a consensus if this is not clear. | Baseline-90 Days |
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