Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis

August 24, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients diagnosed with acute cholecystitis
Time Frame: Within 30 days of enrollment
Diagnosis of acute cholecystitis
Within 30 days of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interval change in gallbladder wall thickness (GWT) on repeat biliary point-of-care ultrasound
Time Frame: 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
Time Frame: 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))
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Within 30 days of enrollment
Need for cholecystectomy, cholecystostomy tube, endoscopic retrograde cholangiopancreatography or other procedural biliary intervention
Within 30 days of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WellSpan Health

Investigators

  • Principal Investigator: Brent Becker, MD, Wellspan Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 17, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2443255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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