Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis

NCT07792200 | Recruiting

• 1 other identifier: 2443255
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis, Acute; Biliary Diseases

Keywords

Acute Cholecystitis; Point of Care Ultrasound; Emergency Department; Biliary Disease

Outcome Measures

Primary Outcomes (1)

• Number of patients diagnosed with acute cholecystitis

  Diagnosis of acute cholecystitis

  Within 30 days of enrollment

Secondary Outcomes (9)

• 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 pericholecystic fluid (PCF) on repeat biliary point-of-care ultrasound

  Within 2-6 hours of initial biliary ultrasound

• Interval change in focal tenderness over the gallbladder (sonographic Murphy's sign (SMS))

  Within 2-6 hours of initial biliary ultrasound

• Interval change in gallbladder diameter (GBD) on repeat biliary point-of-care ultrasound

  Within 2-6 hours of initial ultrasound

• Interval change in common bile duct (CBD) diameter on repeat biliary point-of-care ultrasound

  Within 2-6 hours of initial ultrasound

Study Arms (1)

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

Diagnostic Test: Repeat biliary point of care ultrasound

Interventions

Repeat biliary point of care ultrasound DIAGNOSTIC_TEST

Repeat biliary point of care ultrasound to be performed 2-6 hours following initial ultrasound imaging study

Repeat biliary point-of-care ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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
• hours since initial biliary ultrasound with ongoing symptoms
• General surgery consult placed or additional non-ultrasound advanced imaging ordered
• Fluency in English or Spanish

You may not qualify if:

• \< 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

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

WellSpan Health York Hospital

York, Pennsylvania, 17403, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 41016303 BACKGROUND

• Gallaher JR, Charles A. Acute Cholecystitis: A Review. JAMA. 2022 Mar 8;327(10):965-975. doi: 10.1001/jama.2022.2350.

  PMID: 35258527 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute; Gallbladder Diseases; Emergencies

Condition Hierarchy (Ancestors)

Cholecystitis; Biliary Tract Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brent Becker, MD

  WellSpan Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brent Becker Principal Investigator, MD

CONTACT

717-851-4819; bbecker2@wellspan.org

Kristen Wilhelm Research Coordinator, MS

CONTACT

717-812-5075; kwilhelm6@wellspan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)