Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWellSpan Health
About this trial
The goal of this interventional, prospective study is to determine the clinical utility of a repeat point-of-care ultrasound of the gallbladder in adult emergency department patients with abdominal pain for which initial imaging is not diagnostic. The main question it aims to answer is: Does a repeat ultrasound improve early identification of gallbladder inflammation?
Participants will undergo a repeat ultrasound of the gallbladder while still in the emergency department and will be followed up to determine subsequent diagnoses, disposition, consultations and other clinical information.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years of age
Presenting to the emergency department with abdominal pain with clinical concern for possible acute cholecystitis
Initial biliary US interpreted as normal, equivocal or negative for acute cholecystitis
2-6 hours since initial biliary ultrasound with ongoing symptoms
Disqualifiers
< 18 years of age
> 6 hours since initial biliary US
Asymptomatic/resolved symptoms or pending discharge from the emergency department
Initial ultrasound positive for acute cholecystitis or other findings to explain presenting symptoms
Trial design
Design model
Single group
Treatments tested in this trial
Repeat biliary point of care ultrasound
Diagnostic testRepeat biliary point of care ultrasound to be performed 2-6 hours following initial ultrasound imaging study
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Repeat biliary point-of-care ultrasoundExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients diagnosed with acute cholecystitis
Diagnosis of acute cholecystitis
Time frame
Within 30 days of enrollmentSecondary outcomes
1
Interval change in gallbladder wall thickness (GWT) on repeat biliary point-of-care ultrasound
Interval change in gallbladder wall thickness (GWT) on repeat biliary point-of-care ultrasound compared to initial biliary ultrasound (measured in millimeters).
Time frame
Within 2-6 hours of initial biliary ultrasound2
Interval change in pericholecystic fluid (PCF) on repeat biliary point-of-care ultrasound
Interval change in PCF on repeat biliary point-of-care ultrasound compared to initial biliary ultrasound (assessed as present, absent, increased, decreased or no change).
Time frame
Within 2-6 hours of initial biliary ultrasound3
Interval change in focal tenderness over the gallbladder (sonographic Murphy's sign (SMS))
Interval change in focal tenderness over the gallbladder (SMS) on repeat biliary point-of-care ultrasound compared to initial biliary ultrasound (assessed as present, absent or no change).
Time frame
Within 2-6 hours of initial biliary ultrasound4
Interval change in gallbladder diameter (GBD) on repeat biliary point-of-care ultrasound
Interval change in GBD on repeat biliary point-of-care ultrasound compared to initial biliary ultrasound (measured in centimeters).
Time frame
Within 2-6 hours of initial ultrasoundSponsors and contacts
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Source ClinicalTrials.gov