Acute Flank PainNCT04877886
TCHCCT-Zhong-Xing-Emergency-Department Ultrasound With IV Contrast in Acute Flank Pain
A study testing Ultrasound with IV contrast, CT with IV contrast and Ultrasound without IV contrast in people with Acute Flank Pain, run by Taipei City Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Flank Pain
- What is being tested?
- Ultrasound with IV contrast, CT with IV contrast and Ultrasound without IV contrast
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2021to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute flank pain who visit ER
Who cannot join
- Younger than 18 years old
- Known allergy to contrast
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei City Hospital Zhong-Xing branch
Taipei, 100
Tzu-Yao Hung, MD, 886-2-979305599
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Flank Pain
- Being tested
- Ultrasound with IV contrast, CT with IV contrast, Ultrasound without IV contrast, CT without IV contrast
- Keywords
- Acute flank pain, Ultrasound, IV contrast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound with IV contrastDiagnostic test
To compare the efficiency over the ultrasound scan within contrast
CT with IV contrastDiagnostic test
CT with IV contrast
Ultrasound without IV contrastDiagnostic test
Ultrasound without IV contrast
CT without IV contrastDiagnostic test
CT without IV contrast
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound with IV contrast | Experimental | use ultrasound with IV contrast to perform in acute flank pain patient Receives: Diagnostic Test: Ultrasound with IV contrast |
| CT with IV contrast | Active comparator | to compare with ultrasound with IV contrast in acute flank pain patient Receives: Diagnostic Test: CT with IV contrast |
| Ultrasound without IV contrast | Active comparator | baseline for the Ultrasound with IV contrast Receives: Diagnostic Test: Ultrasound without IV contrast |
| CT without IV contrast | Active comparator | baseline for the CT with IV contrast Receives: Diagnostic Test: CT without IV contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic rate of ultrasound with IV contrast in acute flank pain patient
Evaluate the sensitivity and specificity in ultrasound scan
Measured: The hospitalization of each participant, up to 28 days
Secondary outcomes (1)
To compare the efficiency over the ultrasound and CT scan within or without contrast
compared the sensitivity and specificity between CT and ultrasound scan
Measured: The hospitalization of each participant, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Flank PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hung,Tzu-Yao, Taipei City Hospital
- Investigators
- Tzu-Yao Hung, MD, Study director, Taipei City Hospital ZhongXing Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877886
- Sponsor's protocol ID
- TCHCCT-ZXERUSC
- Status last verified
- May 2021
- First submitted
- 29 Apr 2021
- Last updated
- 11 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique for the Assessment of Non-traumatic Pain Diagnosis in the Emergency Department.
- ClinicalTrials.gov ID
- NCT04877886
- Acronym / sponsor ID
- TCHCCT-ZXERUSC
- Conditions
- Acute Flank Pain
- Keywords
- Acute flank pain, Ultrasound, IV contrast
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ultrasound with IV contrast | Experimental | Diagnostic Test: Ultrasound with IV contrastuse ultrasound with IV contrast to perform in acute flank pain patient |
| CT with IV contrast | Active comparator | Diagnostic Test: CT with IV contrastto compare with ultrasound with IV contrast in acute flank pain patient |
| Ultrasound without IV contrast | Active comparator | Diagnostic Test: Ultrasound without IV contrastbaseline for the Ultrasound with IV contrast |
| CT without IV contrast | Active comparator | Diagnostic Test: CT without IV contrastbaseline for the CT with IV contrast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute flank pain who visit ER
Key exclusion criteria (2 listed)
- Younger than 18 years old
- Known allergy to contrast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound with IV contrastTo compare the efficiency over the ultrasound scan within contrast | Diagnostic test | Ultrasound with IV contrast |
| CT with IV contrastCT with IV contrast | Diagnostic test | CT with IV contrast |
| Ultrasound without IV contrastUltrasound without IV contrast | Diagnostic test | Ultrasound without IV contrast |
| CT without IV contrastCT without IV contrast | Diagnostic test | CT without IV contrast |
Primary outcome
The diagnostic rate of ultrasound with IV contrast in acute flank pain patient
Time frame: The hospitalization of each participant, up to 28 days
Evaluate the sensitivity and specificity in ultrasound scan
1 secondary outcome
To compare the efficiency over the ultrasound and CT scan within or without contrast
Time frame: The hospitalization of each participant, up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzu-Yao Hung, MD study director
Taipei City Hospital ZhongXing Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound with IV contrast, CT with IV contrast and Ultrasound without IV contrast in people with Acute Flank Pain, run by Taipei City Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu-Yao Hung, MD (886-979305599, bryansolitude@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic rate of ultrasound with IV contrast in acute flank pain patient (time frame: The hospitalization of each participant, up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.