Biliary Diseases, Cholecystitis, Acute
Conditions
Keywords
Acute Cholecystitis, Point of Care Ultrasound, Emergency Department, Biliary Disease
Brief summary
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.
Detailed description
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 1. To assess the role of a repeated biliary point-of-care ultrasound (POCUS) examination in ED patients with an initial US equivocal or negative for acute cholecystitis. 2. To determine if a repeated biliary POCUS examination in the ED improves the diagnostic accuracy for acute cholecystitis. 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.
Interventions
DIAGNOSTIC_TESTRepeat biliary point of care ultrasound
Repeat biliary point of care ultrasound to be performed 2-6 hours following initial ultrasound imaging study
Sponsors
WellSpan Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 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 * General surgery consult placed or additional non-ultrasound advanced imaging ordered * Fluency in English or Spanish
Exclusion criteria
* \< 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 * Baseline ascites * Prior cholecystectomy * Unable or unwilling to provide consent * Presenting to a facility other than study site emergency department * Transferred patients from outside facilities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients diagnosed with acute cholecystitis | Within 30 days of enrollment | Diagnosis of acute cholecystitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients requiring additional non-ultrasound imaging modalities | Within 30 days of enrollment | Use of other non-ultrasound imaging modalities, including computed tomography, hepatobiliary iminodiacetic acid scan, or magnetic resonance imaging. |
| Number of patient requiring biliary interventions | Within 30 days of enrollment | Need for cholecystectomy, cholecystostomy tube, endoscopic retrograde cholangiopancreatography or other procedural biliary intervention |
| Interval change in gallbladder wall thickness (GWT) on repeat biliary point-of-care ultrasound | Within 2-6 hours of initial biliary ultrasound | Interval change in gallbladder wall thickness (GWT) on repeat biliary point-of-care ultrasound compared to initial biliary ultrasound (measured in millimeters). |
| Interval change in pericholecystic fluid (PCF) on repeat biliary point-of-care ultrasound | Within 2-6 hours of initial biliary 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). |
| Interval change in focal tenderness over the gallbladder (sonographic Murphy's sign (SMS)) | Within 2-6 hours of initial biliary ultrasound | 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). |
| Interval change in gallbladder diameter (GBD) on repeat biliary point-of-care ultrasound | Within 2-6 hours of initial ultrasound | Interval change in GBD on repeat biliary point-of-care ultrasound compared to initial biliary ultrasound (measured in centimeters). |
| Interval change in common bile duct (CBD) diameter on repeat biliary point-of-care ultrasound | Within 2-6 hours of initial ultrasound | Interval change in CBD diameter on repeat biliary point-of-care ultrasound compared to initial biliary ultrasound (measured in millimeters). |
| Number of patients requiring specialty consultation | Within 30 days of enrollment | Need for surgery, gastroenterology or other specialty consultation |
| Number of patients diagnosed with other biliary pathology | Within 30 days of enrollment | Diagnosis of other biliary pathology, including choledocholithiasis, cholangitis, pancreatitis, biliary dyskinesia or other new diagnosis involving the gallbladder, biliary ducts or pancreas. |
Countries
United States
Contacts
CONTACTBrent Becker Principal Investigator, MD
CONTACTKristen Wilhelm Research Coordinator, MS
PRINCIPAL_INVESTIGATORBrent Becker, MD
WellSpan Health
Outcome results
None listed