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

NCT ID: NCT04877886

Last Updated: 2021-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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Acute Flank Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Ultrasound with IV contrast

use ultrasound with IV contrast to perform in acute flank pain patient

Group Type EXPERIMENTAL

Ultrasound with IV contrast

Intervention Type DIAGNOSTIC_TEST

To compare the efficiency over the ultrasound scan within contrast

CT with IV contrast

to compare with ultrasound with IV contrast in acute flank pain patient

Group Type ACTIVE_COMPARATOR

CT with IV contrast

Intervention Type DIAGNOSTIC_TEST

CT with IV contrast

Ultrasound without IV contrast

baseline for the Ultrasound with IV contrast

Group Type ACTIVE_COMPARATOR

Ultrasound without IV contrast

Intervention Type DIAGNOSTIC_TEST

Ultrasound without IV contrast

CT without IV contrast

baseline for the CT with IV contrast

Group Type ACTIVE_COMPARATOR

CT without IV contrast

Intervention Type DIAGNOSTIC_TEST

CT without IV contrast

Interventions

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Ultrasound with IV contrast

To compare the efficiency over the ultrasound scan within contrast

Intervention Type DIAGNOSTIC_TEST

CT with IV contrast

CT with IV contrast

Intervention Type DIAGNOSTIC_TEST

Ultrasound without IV contrast

Ultrasound without IV contrast

Intervention Type DIAGNOSTIC_TEST

CT without IV contrast

CT without IV contrast

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Acute flank pain who visit ER

Exclusion Criteria

* Younger than 18 years old
* Known allergy to contrast
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hung,Tzu-Yao

Emergency Medicine Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tzu-Yao Hung, MD

Role: STUDY_DIRECTOR

Taipei City Hospital ZhongXing Branch

Locations

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Taipei City Hospital Zhong-Xing branch

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Tzu-Yao Hung, MD

Role: CONTACT

886-979305599

Facility Contacts

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Tzu-Yao Hung, MD

Role: primary

886-2-979305599

Other Identifiers

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TCHCCT-ZXERUSC

Identifier Type: -

Identifier Source: org_study_id

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