Clinical trial NCT04877886: TCHCCT-Zhong-Xing-Emergency-Department Ultrasound With IV Contrast in Acute Flank Pain
Official title: A Novel Technique for the Assessment of Non-traumatic Pain Diagnosis in the Emergency Department.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Flank Pain
Keywords: Acute flank pain
Ultrasound
IV contrast
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2021-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the efficiency of ultrasound with IV contrast and compare this with the Computed Tomography in acute flank pain patient at Emergency Department.

Detailed description: Acute flank pain is a common chief complaint in emergency departments (ED), but it is a challenge for physicians in ED to accurately diagnose. It can cause variable diseases and is in many cases lethal (e.g. aortic dissection, ruptured aortic aneurysm, renal artery dissection, ruptured tumor, etc). The computed tomography scan with IV contrast is an ideal tool to diagnose due to its high sensitivity and specificity and is a golden standard examination. However, currently point-of-care ultrasound is routinely used as first-line technique. As this procedure is non-invasive and has no radiative effect, it is considered more logical, especially for those critical patients who are not able to move and perform the CT scan. Furthermore, the iodine contrast of CT scan is known as renal toxicity and should be used with caution in patient with hyperthyroidism and allergy to the contrast. The radiation of CT scan would be harmful to the pregnant patient as well.

IV contrast ultrasound is a novel technique nowadays and it is widely used in diagnosing breast, liver, renal and pancreatic tumors. The ultrasound contrast using air microbubbles could enhance the scanning quality and also has high sensitivity and specificity. In ED, ultrasound with contrast now could be applied to the abdominal trauma and pediatric injury. For those patients with poor renal function, thyroid disease and pregnant women who cannot undergo IV contrast CT, IV contrast ultrasound provides a faster and safer way to evaluate patients in ED. We compared CT and ultrasound with IV contrast to determine the difference in efficiency between both examinations.

Eligibility criteria: Inclusion Criteria:

* Acute flank pain who visit ER

Exclusion Criteria:

* Younger than 18 years old
* Known allergy to contrast

Primary outcomes:
measure: The diagnostic rate of ultrasound with IV contrast in acute flank pain patient
timeFrame: The hospitalization of each participant, up to 28 days
Secondary outcomes:
measure: To compare the efficiency over the ultrasound and CT scan within or without contrast
timeFrame: The hospitalization of each participant, up to 28 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital Zhong-Xing branch
Study officials:
affiliation: Taipei City Hospital ZhongXing Branch
name: Tzu-Yao Hung, MD
role: STUDY_DIRECTOR
References: