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Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis

24 augustus 2026 bijgewerkt door: WellSpan Health

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

90

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Brent Becker Principal Investigator, MD
  • Telefoonnummer: 717-851-4819
  • E-mail: bbecker2@wellspan.org

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Repeat biliary point-of-care ultrasound
Repeat point-of-care ultrasound to be performed 2-6 hours from time of initial ultrasound imaging study
Diagnostische toets: Repeat biliary point of care ultrasound
Repeat biliary point of care ultrasound to be performed 2-6 hours following initial ultrasound imaging study

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of patients diagnosed with acute cholecystitis
Tijdsspanne: Within 30 days of enrollment
Diagnosis of acute cholecystitis
Within 30 days of enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Interval change in gallbladder wall thickness (GWT) on repeat biliary point-of-care ultrasound
Tijdsspanne: 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).
Within 2-6 hours of initial biliary ultrasound
Interval change in pericholecystic fluid (PCF) on repeat biliary point-of-care ultrasound
Tijdsspanne: 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).
Within 2-6 hours of initial biliary ultrasound
Interval change in focal tenderness over the gallbladder (sonographic Murphy's sign (SMS))
Tijdsspanne: 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).
Within 2-6 hours of initial biliary ultrasound
Interval change in gallbladder diameter (GBD) on repeat biliary point-of-care ultrasound
Tijdsspanne: 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).
Within 2-6 hours of initial ultrasound
Interval change in common bile duct (CBD) diameter on repeat biliary point-of-care ultrasound
Tijdsspanne: 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).
Within 2-6 hours of initial ultrasound
Number of patients diagnosed with other biliary pathology
Tijdsspanne: 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.
Within 30 days of enrollment
Number of patients requiring specialty consultation
Tijdsspanne: Within 30 days of enrollment
Need for surgery, gastroenterology or other specialty consultation
Within 30 days of enrollment
Number of patients requiring additional non-ultrasound imaging modalities
Tijdsspanne: Within 30 days of enrollment
Use of other non-ultrasound imaging modalities, including computed tomography, hepatobiliary iminodiacetic acid scan, or magnetic resonance imaging.
Within 30 days of enrollment
Number of patient requiring biliary interventions
Tijdsspanne: Within 30 days of enrollment
Need for cholecystectomy, cholecystostomy tube, endoscopic retrograde cholangiopancreatography or other procedural biliary intervention
Within 30 days of enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

WellSpan Health

Onderzoekers

  • Hoofdonderzoeker: Brent Becker, MD, Wellspan Health

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2026

Primaire voltooiing (Geschat)

1 juli 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

17 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 augustus 2026

Eerst geplaatst (Werkelijk)

28 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

24 augustus 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2443255

Plan Individuele Deelnemersgegevens (IPD)

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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