An interventional study of Repeat biliary point of care ultrasound in Cholecystitis, Acute and Biliary Diseases, sponsored by WellSpan Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by WellSpan Health · Not applicable, Interventional, and Diagnostic
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.
Acute cholecystitis is a frequent cause of abdominal pain leading to emergency department (ED) evaluation and accounts for approximately 200,000 cases annually in the US (1). Ultrasound (US) is the first-line diagnostic test, but early disease may produce equivocal or negative findings. This diagnostic uncertainty can lead to delayed treatment or the need for additional imaging, such as computed tomography (CT) or a hepatobiliary iminodiacetic acid (HIDA) scan. Recent research has shown that inflammatory changes of the gallbladder may evolve over several hours during the acute presentation. Repeat point-of-care ultrasound (POCUS) evaluations have the potential to identify interval development of clinically relevant findings, including gallbladder wall thickening, pericholecystic fluid, common bile duct dilation, and focal tenderness (sonographic Murphy's sign) (2). Despite this rationale, there is currently no prospective evidence supporting repeat POCUS examinations in ED patients with suspected cholecystitis.
Objectives
The investigators hypothesize that a repeat biliary POCUS will improve diagnostic accuracy for acute cholecystitis in ED patients with an initially equivocal or negative ultrasound.
The investigators will conduct a prospective, single arm, interventional cohort study of adult ED patients presenting with right upper quadrant pain (RUQ) and clinical concern for acute cholecystitis. Patients will be eligible for enrollment if they demonstrate initial US that is negative or equivocal for acute cholecystitis, as well as ongoing symptoms prompting a general surgery consult or additional non-US advanced imaging. Consented study participants will undergo repeat biliary POCUS performed by credentialed ED physicians within 2-6 hours of their baseline US. Sonographic findings will be recorded with particular attention to interval changes to the gallbladder since the prior US. Additional data will be collected from the electronic medical record regarding clinical endpoints, including subsequent diagnoses of acute biliary pathology and the need for additional non-US imaging, consultation, or procedural intervention. The diagnostic accuracy and yield of repeat biliary POCUS will be calculated.
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
This study's planned enrollment of 90 is close to the median of 90 across 84 interventional studies indexed under Cholecystitis, Acute.
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Exclusion Criteria:
Repeat point-of-care ultrasound to be performed 2-6 hours from time of initial ultrasound imaging study
Diagnostic Test: Repeat biliary point of care ultrasound
Repeat biliary point of care ultrasound to be performed 2-6 hours following initial ultrasound imaging study
Number of patients diagnosed with acute cholecystitis
Diagnosis of acute cholecystitis
Time frame: Within 30 days of enrollment
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 ultrasound
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 ultrasound
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 ultrasound
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 ultrasound
Interval change in common bile duct (CBD) diameter on repeat biliary point-of-care ultrasound
Interval change in CBD diameter on repeat biliary point-of-care ultrasound compared to initial biliary ultrasound (measured in millimeters).
Time frame: Within 2-6 hours of initial ultrasound
Number of patients diagnosed with other biliary pathology
Diagnosis of other biliary pathology, including choledocholithiasis, cholangitis, pancreatitis, biliary dyskinesia or other new diagnosis involving the gallbladder, biliary ducts or pancreas.
Time frame: Within 30 days of enrollment
Number of patients requiring specialty consultation
Need for surgery, gastroenterology or other specialty consultation
Time frame: Within 30 days of enrollment
Number of patients requiring additional non-ultrasound imaging modalities
Use of other non-ultrasound imaging modalities, including computed tomography, hepatobiliary iminodiacetic acid scan, or magnetic resonance imaging.
Time frame: Within 30 days of enrollment
Number of patient requiring biliary interventions
Need for cholecystectomy, cholecystostomy tube, endoscopic retrograde cholangiopancreatography or other procedural biliary intervention
Time frame: Within 30 days of enrollment
Plan to share: No
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