TCHCCT-Zhong-Xing-Emergency-Department Ultrasound With IV Contrast in Acute Flank Pain

Not Applicable

• Conditions: Acute Flank Pain
• Interventions: Diagnostic Test: Ultrasound with IV contrast; Diagnostic Test: CT with IV contrast; Diagnostic Test: CT without IV contrast; Diagnostic Test: Ultrasound without IV contrast

• Registration Number: NCT04877886
• Lead Sponsor: Taipei City Hospital

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.

Study Timeline

• Study First Submitted: 2021-04-29
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-07
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11
• Study Start: 2021-06-01
• Primary Completion: 2023-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Acute flank pain who visit ER

Exclusion Criteria

• Younger than 18 years old
• Known allergy to contrast

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ultrasound with IV contrast	Ultrasound with IV contrast	use ultrasound with IV contrast to perform in acute flank pain patient
CT with IV contrast	CT with IV contrast	to compare with ultrasound with IV contrast in acute flank pain patient
CT without IV contrast	CT without IV contrast	baseline for the CT with IV contrast
Ultrasound without IV contrast	Ultrasound without IV contrast	baseline for the Ultrasound with IV contrast

Primary Outcome Measures

Name	Time	Method
The diagnostic rate of ultrasound with IV contrast in acute flank pain patient	The hospitalization of each participant, up to 28 days	Evaluate the sensitivity and specificity in ultrasound scan

Secondary Outcome Measures

Name	Time	Method
To compare the efficiency over the ultrasound and CT scan within or without contrast	The hospitalization of each participant, up to 28 days	compared the sensitivity and specificity between CT and ultrasound scan

Trial Locations

Locations (1)

Taipei City Hospital Zhong-Xing branch; 🇨🇳 Taipei, Taiwan