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

A Novel Technique for the Assessment of Non-traumatic Pain Diagnosis in the Emergency Department.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Flank Pain
• Intervention / Treatment: Diagnostic test: Ultrasound with IV contrast; Diagnostic test: CT with IV contrast; Diagnostic test: Ultrasound without IV contrast; Diagnostic test: CT without IV contrast

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tzu-Yao Hung, MD; Phone Number: 886-979305599; Email: bryansolitude@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Taipei City Hospital Zhong-Xing branch
    • Contact: Tzu-Yao Hung, MD; Phone Number: 886-2-979305599

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Acute flank pain who visit ER

Exclusion Criteria:

• Younger than 18 years old
• Known allergy to contrast

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound with IV contrast; use ultrasound with IV contrast to perform in acute flank pain patient	Diagnostic test: Ultrasound with IV contrast; To compare the efficiency over the ultrasound scan within contrast
Active Comparator: CT with IV contrast; to compare with ultrasound with IV contrast in acute flank pain patient	Diagnostic test: CT with IV contrast; CT with IV contrast
Active Comparator: Ultrasound without IV contrast; baseline for the Ultrasound with IV contrast	Diagnostic test: Ultrasound without IV contrast; Ultrasound without IV contrast
Active Comparator: CT without IV contrast; baseline for the CT with IV contrast	Diagnostic test: CT without IV contrast; CT without IV contrast

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Investigators: Study Director: Tzu-Yao Hung, MD, Taipei City Hospital ZhongXing Branch

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; IV contrast; Acute flank pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Flank Pain
• Other Study ID Numbers: TCHCCT-ZXERUSC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No