Cholecystitis, AcuteNCT07792200
Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
A study testing Repeat biliary point of care ultrasound in people with Cholecystitis, Acute and Biliary Diseases, run by WellSpan Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Acute, Biliary Diseases
- What is being tested?
- Repeat biliary point of care ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 Dec 2028
- Phase
- Interventional
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
- ≥ 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
Who cannot join
- < 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
Show all 9Show fewer
- Unable or unwilling to provide consent
- Presenting to a facility other than study site emergency department
- Transferred patients from outside facilities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
WellSpan Health York Hospital
York, Pennsylvania, 17403
Kristen Wilhelm, MS, 717-812-5075, kwilhelm6@wellspan.org
Brent Becker, MD, 717-851-4819, bbecker2@wellspan.org
About this study
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.
Read the 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
- 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.
- 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.
- Conditions
- Cholecystitis, Acute, Biliary Diseases
- Being tested
- Repeat biliary point of care ultrasound
- Keywords
- Acute Cholecystitis, Point of Care Ultrasound, Emergency Department, Biliary Disease
- Medical subject headings
- Cholecystitis, Acute, Gallbladder Diseases, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeat biliary point of care ultrasoundDiagnostic test
Repeat biliary point of care ultrasound to be performed 2-6 hours following initial ultrasound imaging study
| Study group | Role | What they receive |
|---|---|---|
| Repeat biliary point-of-care ultrasound | Experimental | Repeat point-of-care ultrasound to be performed 2-6 hours from time of initial ultrasound imaging study Receives: Diagnostic Test: Repeat biliary point of care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients diagnosed with acute cholecystitis
Diagnosis of acute cholecystitis
Measured: Within 30 days of enrollment
Secondary outcomes (9)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Within 30 days of enrollment
Number of patients requiring specialty consultation
Need for surgery, gastroenterology or other specialty consultation
Measured: 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.
Measured: Within 30 days of enrollment
Number of patient requiring biliary interventions
Need for cholecystectomy, cholecystostomy tube, endoscopic retrograde cholangiopancreatography or other procedural biliary intervention
Measured: Within 30 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Jun 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis, AcuteStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brent Becker, MD, Principal investigator, WellSpan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792200
- Sponsor's protocol ID
- 2443255
- Status last verified
- Jun 2026
- First submitted
- 17 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ivanov D, Cannata D, Chin KA, She T, Lotterman S, Delgado J, Herbst MK. Evolution of Secondary Findings in Acute Cholecystitis: A Temporal Analysis from Point-of-Care Ultrasound to Subsequent Imaging. J Emerg Med. 2025 Nov;78:266-274. doi: 10.1016/j.jemermed.2025.03.020. Epub 2025 Mar 26.
PubMed 41016303Gallaher JR, Charles A. Acute Cholecystitis: A Review. JAMA. 2022 Mar 8;327(10):965-975. doi: 10.1001/jama.2022.2350.
PubMed 35258527