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Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis

24 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

90

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Brent Becker Principal Investigator, MD
  • Número de teléfono: 717-851-4819
  • Correo electrónico: bbecker2@wellspan.org

Copia de seguridad de contactos de estudio

  • Nombre: Kristen Wilhelm Research Coordinator, MS
  • Número de teléfono: 717-812-5075
  • Correo electrónico: kwilhelm6@wellspan.org

Ubicaciones de estudio

  • Estados Unidos
    • Pennsylvania
      • York, Pennsylvania, Estados Unidos, 17403
        • Reclutamiento
        • WellSpan Health York Hospital
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Repeat biliary point-of-care ultrasound
Repeat point-of-care ultrasound to be performed 2-6 hours from time of initial ultrasound imaging study
Prueba de diagnóstico: Repeat biliary point of care ultrasound
Repeat biliary point of care ultrasound to be performed 2-6 hours following initial ultrasound imaging study

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of patients diagnosed with acute cholecystitis
Periodo de tiempo: Within 30 days of enrollment
Diagnosis of acute cholecystitis
Within 30 days of enrollment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Interval change in gallbladder wall thickness (GWT) on repeat biliary point-of-care ultrasound
Periodo de tiempo: 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
Periodo de tiempo: 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))
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Within 30 days of enrollment
Need for cholecystectomy, cholecystostomy tube, endoscopic retrograde cholangiopancreatography or other procedural biliary intervention
Within 30 days of enrollment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

WellSpan Health

Investigadores

  • Investigador principal: Brent Becker, MD, Wellspan Health

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2026

Finalización primaria (Estimado)

1 de julio de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

17 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de agosto de 2026

Publicado por primera vez (Actual)

28 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de agosto de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2443255

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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