Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2020
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Study Aim: The specific aim of this study is to prospectively validate the previously derived decision rule for obtaining a Flank Pain Protocol (FPP) CT scan in suspected renal colic.

The investigators will integrate the derived clinical decision rule from the ongoing retrospective analysis with gestalt clinician pre-test probability, point of care ultrasound, and plain radiography (when appropriate) to prospectively and observationally test the rule at two distinct clinical settings. CT results and 90-day follow-up will be used to determine predefined outcomes.

Study Hypothesis: Prospective observational testing of a clinical decision rule, combined with point of care ultrasound and plain radiography when appropriate, will categorize >85% of patients who will require intervention, validating a decision rule to avoid unnecessary CT.

This amendment comes from recent evidence and work at our institution to develop an "ultra-low dose" CT scan protocol (ULDCT) with an effective radiation dose close to that of a plain film of the abdomen (KUB), or near 1mSv (compared to 8.5mSv in current practice). While we expect the ULDCT to be better than a KUB at localizing and characterizing kidney stones, what is unknown is how the loss in resolution with an ultra-low dose CT protocol might affect this localization and characterization of stones relative to a regular dose CT (current protocol), as well as the ability to find alternate diagnoses. Incorporating this additional imaging study in a subgroup of patients during the observational phase will allow us to determine test characteristics of the ULDCT that will allow incorporation into the prospective phase. This will hopefully provide excellent evidence about how to implement an ultra-low dose CT scan in practice, ultimately leading to a dramatic reduction in radiation exposure for a large number of patients at Yale and other sites.

We filed an amendment 11-15-2011. This amendment comes from recent evidence and work at our institution to develop an "ultra-low dose" CT scan protocol (ULDCT) with an effective radiation dose close to that of a plain film of the abdomen (KUB), or near 1mSv (compared to 8.5mSv in current practice). While we expect the ULDCT to be better than a KUB at localizing and characterizing kidney stones, what is unknown is how the loss in resolution with an ultra-low dose CT protocol might affect this localization and characterization of stones relative to a regular dose CT (current protocol), as well as the ability to find alternate diagnoses. Incorporating this additional imaging study in a subgroup of patients during the observational phase will allow us to determine test characteristics of the ULDCT that will allow incorporation into the prospective phase. This will hopefully provide excellent evidence about how to implement an ultra-low dose CT scan in practice, ultimately leading to a dramatic reduction in radiation exposure for a large number of patients at Yale and other sites.

This amendment comes from recent evidence and work at our institution to develop an "ultra-low dose" CT scan protocol (ULDCT) with an effective radiation dose close to that of a plain film of the abdomen (KUB), or near 1mSv (compared to 8.5mSv in current practice). While we expect the ULDCT to be better than a KUB at localizing and characterizing kidney stones, what is unknown is how the loss in resolution with an ultra-low dose CT protocol might affect this localization and characterization of stones relative to a regular dose CT (current protocol), as well as the ability to find alternate diagnoses. Incorporating this additional imaging study in a subgroup of patients during the observational phase will allow us to determine test characteristics of the ULDCT that will allow incorporation into the prospective phase. This will hopefully provide excellent evidence about how to implement an ultra-low dose CT scan in practice, ultimately leading to a dramatic reduction in radiation exposure for a large number of patients at Yale and other sites.

Future Direction: Ultimately the investigators intend to implement the validated decision rule at both study sites to evaluate further the feasibility, physician acceptance and comparative effectiveness of our rule. Using standard dissemination techniques and integration of the rule into the computerized physician order entry (CPOE) system at our institutions the investigators will determine the actual reduction in the number of FPP CT scans ordered, clinical outcomes based on 90-day follow up, survey of physician acceptance of the rule as well as an comparative effective analysis. The investigators will submit an application at a later date nearing the end of our projected enrollment for this study.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Shoreline Medical Center Guilford Connecticut
United States Yale University, Emergency Department New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (14)

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 allClick here to view all references

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT05982483 - Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain N/A
Completed NCT04744246 - Muscle Activity During Load Carriage in ROTC Cadets N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Active, not recruiting NCT03680846 - Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain N/A
Completed NCT05597189 - Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain N/A
Completed NCT05342181 - Static and Dynamic Core Stability Exercises in Potpartum Back Pain N/A
Completed NCT02955342 - Back and Neck Pain in Adolescence
Not yet recruiting NCT02536274 - "Examination of the Impact of a Dynamic Flexion Orthosis (Dynaflex®Ottobock) or of a Back Bandage (Lumbo Sensa®Ottobock) on the Voluntary Activation of the Back Muscles in Patients With Specific Back Pain" N/A
Completed NCT02704845 - Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain N/A
Recruiting NCT02237105 - The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery N/A
Enrolling by invitation NCT02485795 - Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management N/A
Completed NCT02254694 - The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body N/A
Terminated NCT02239627 - Epidural Clonidine Versus Corticosteroid for Low Back Pain N/A
Completed NCT02609009 - Back Pain and Spinal Manipulation in Adolescent Scoliosis N/A
Completed NCT00986180 - NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain Phase 3
Terminated NCT00769626 - Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy Phase 3
Completed NCT00771758 - Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis Phase 3
Withdrawn NCT00231374 - Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning N/A
Completed NCT00103675 - Sensor Measurement of Acupuncture Needle Manipulation Phase 1
Completed NCT00454064 - Cognitive-behavioural Treatment of Chronic Back Pain Phase 3