Limit Computed Tomography (CT) Scanning in Suspected Renal Colic

NCT01352676 | Completed

• 2 other identifiers: 1104008278HS018322
• Study Type: observational
• Target: 635
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Renal Colic; Flank Pain; Back Pain

Keywords

renal colic; flank pain; back pain

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population will be all patients aged 18 or above presenting to the Yale New Haven Hospital (YNHH) ED and Shoreline Medical Center (SMC) ED for whom a FPP CT scan is ordered by the treating physician for suspected renal colic. A total of 800-1000 patients will be enrolled over a 1.5 year period 6-2011 to 1-2013, matching the sex/race/ethnicity makeup of that found for the retrospective study. The population of the primary catchment area for YNHH is 350,000 and includes a diverse ethnic and cultural mix. Women and minorities are strongly represented in the population. Women represent approximately 51% of the ED population. The racial mix is approximately 50% White, not of Hispanic Origin; 33% Black, not of Hispanic Origin, 15% Hispanic; 1% Asian and 1% other. The ethnicity of SMC patients is mostly White and 54% female.

You may qualify if:

• Patients who present to the adult YNHH ED and Shoreline Medical Center SMC ED who are
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (2)

Shoreline Medical Center

Guilford, Connecticut, 06437, United States

Location

Yale University, Emergency Department

New Haven, Connecticut, 06519, United States

Location

Related Publications (16)

• Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.

  PMID: 18046031 BACKGROUND

• 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. doi: 10.2214/ajr.176.2.1760289.

  PMID: 11159059 BACKGROUND

• Medicare Part B Imaging Services. General Accounting Office. Washington D.C., 2008.

  BACKGROUND

• 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. doi: 10.1088/0952-4746/20/4/301.

  PMID: 11140709 BACKGROUND

• 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. doi: 10.1148/radiol.2303021726. Epub 2004 Jan 22.

  PMID: 14739312 BACKGROUND

• 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. doi: 10.1016/j.rcl.2007.04.001.

  PMID: 17601499 BACKGROUND

• 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. No abstract available.

  PMID: 11037484 BACKGROUND

• Teichman JM. Clinical practice. Acute renal colic from ureteral calculus. N Engl J Med. 2004 Feb 12;350(7):684-93. doi: 10.1056/NEJMcp030813. No abstract available.

  PMID: 14960744 BACKGROUND

• Ripolles T, Errando J, Agramunt M, Martinez MJ. Ureteral colic: US versus CT. Abdom Imaging. 2004 Mar-Apr;29(2):263-6. doi: 10.1007/s00261-003-0098-7. No abstract available.

  PMID: 15290956 BACKGROUND

• 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. doi: 10.2214/ajr.178.2.1780379.

  PMID: 11804898 BACKGROUND

• 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. doi: 10.1148/radiol.2252020101.

  PMID: 12409578 BACKGROUND

• Ripolles T, Agramunt M, Errando J, Martinez 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. doi: 10.1007/s00330-003-1924-6. Epub 2003 Jun 19.

  PMID: 12819916 BACKGROUND

• 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. doi: 10.1016/j.jemermed.2006.12.035. Epub 2007 Jun 5.

  PMID: 17692768 BACKGROUND

• 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. doi: 10.1007/BF02599984.

  PMID: 8441076 BACKGROUND

• Moore CL, Bomann S, Daniels B, Luty S, Molinaro A, Singh D, Gross CP. Derivation and validation of a clinical prediction rule for uncomplicated ureteral stone--the STONE score: retrospective and prospective observational cohort studies. BMJ. 2014 Mar 26;348:g2191. doi: 10.1136/bmj.g2191.

  PMID: 24671981 DERIVED

• Lukasiewicz A, Bhargavan-Chatfield M, Coombs L, Ghita M, Weinreb J, Gunabushanam G, Moore CL. Radiation dose index of renal colic protocol CT studies in the United States: a report from the American College of Radiology National Radiology Data Registry. Radiology. 2014 May;271(2):445-51. doi: 10.1148/radiol.14131601. Epub 2014 Jan 27.

  PMID: 24484064 DERIVED

MeSH Terms

Conditions

Renal Colic; Flank Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher L Moore, MD

  Yale University School of Medicine, Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: May 12, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

US (2)