TCHCCT-Zhong-Xing-Emergency-Department Ultrasound With IV Contrast in Acute Flank Pain
Primary Purpose
Acute Flank Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ultrasound with IV contrast
CT with IV contrast
Ultrasound without IV contrast
CT without IV contrast
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Flank Pain focused on measuring Acute flank pain, Ultrasound, IV contrast
Eligibility Criteria
Inclusion Criteria:
- Acute flank pain who visit ER
Exclusion Criteria:
- Younger than 18 years old
- Known allergy to contrast
Sites / Locations
- Taipei City Hospital Zhong-Xing branch
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
Ultrasound with IV contrast
CT with IV contrast
Ultrasound without IV contrast
CT without IV contrast
Arm Description
use ultrasound with IV contrast to perform in acute flank pain patient
to compare with ultrasound with IV contrast in acute flank pain patient
baseline for the Ultrasound with IV contrast
baseline for the CT with IV contrast
Outcomes
Primary Outcome Measures
The diagnostic rate of ultrasound with IV contrast in acute flank pain patient
Evaluate the sensitivity and specificity in ultrasound scan
Secondary Outcome Measures
To compare the efficiency over the ultrasound and CT scan within or without contrast
compared the sensitivity and specificity between CT and ultrasound scan
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04877886
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei City Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Flank Pain
Keywords
Acute flank pain, Ultrasound, IV contrast
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound with IV contrast
Arm Type
Experimental
Arm Description
use ultrasound with IV contrast to perform in acute flank pain patient
Arm Title
CT with IV contrast
Arm Type
Active Comparator
Arm Description
to compare with ultrasound with IV contrast in acute flank pain patient
Arm Title
Ultrasound without IV contrast
Arm Type
Active Comparator
Arm Description
baseline for the Ultrasound with IV contrast
Arm Title
CT without IV contrast
Arm Type
Active Comparator
Arm Description
baseline for the CT with IV contrast
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound with IV contrast
Intervention Description
To compare the efficiency over the ultrasound scan within contrast
Intervention Type
Diagnostic Test
Intervention Name(s)
CT with IV contrast
Intervention Description
CT with IV contrast
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound without IV contrast
Intervention Description
Ultrasound without IV contrast
Intervention Type
Diagnostic Test
Intervention Name(s)
CT without IV contrast
Intervention Description
CT without IV contrast
Primary Outcome Measure Information:
Title
The diagnostic rate of ultrasound with IV contrast in acute flank pain patient
Description
Evaluate the sensitivity and specificity in ultrasound scan
Time Frame
The hospitalization of each participant, up to 28 days
Secondary Outcome Measure Information:
Title
To compare the efficiency over the ultrasound and CT scan within or without contrast
Description
compared the sensitivity and specificity between CT and ultrasound scan
Time Frame
The hospitalization of each participant, up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute flank pain who visit ER
Exclusion Criteria:
Younger than 18 years old
Known allergy to contrast
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzu-Yao Hung, MD
Phone
886-979305599
Email
bryansolitude@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzu-Yao Hung, MD
Organizational Affiliation
Taipei City Hospital ZhongXing Branch
Official's Role
Study Director
Facility Information:
Facility Name
Taipei City Hospital Zhong-Xing branch
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tzu-Yao Hung, MD
Phone
886-2-979305599
12. IPD Sharing Statement
Learn more about this trial
TCHCCT-Zhong-Xing-Emergency-Department Ultrasound With IV Contrast in Acute Flank Pain
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