Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Brent Becker Principal Investigator, MD
- 電話番号:717-851-4819
- メール:bbecker2@wellspan.org
研究連絡先のバックアップ
- 名前:Kristen Wilhelm Research Coordinator, MS
- 電話番号:717-812-5075
- メール:kwilhelm6@wellspan.org
研究場所
-
-
Pennsylvania
-
York、Pennsylvania、アメリカ、17403
- 募集
- WellSpan Health York Hospital
-
コンタクト:
- Brent Becker, MD
- 電話番号:717-851-4819
- メール:bbecker2@wellspan.org
-
コンタクト:
- Kristen Wilhelm, MS
- 電話番号:717-812-5075
- メール:kwilhelm6@wellspan.org
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Repeat biliary point-of-care ultrasound
Repeat point-of-care ultrasound to be performed 2-6 hours from time of initial ultrasound imaging study
|
Repeat biliary point of care ultrasound to be performed 2-6 hours following initial ultrasound imaging study
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of patients diagnosed with acute cholecystitis
時間枠:Within 30 days of enrollment
|
Diagnosis of acute cholecystitis
|
Within 30 days of enrollment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Interval change in gallbladder wall thickness (GWT) on repeat biliary point-of-care ultrasound
時間枠: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
時間枠: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))
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Within 30 days of enrollment
|
Need for cholecystectomy, cholecystostomy tube, endoscopic retrograde cholangiopancreatography or other procedural biliary intervention
|
Within 30 days of enrollment
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Brent Becker, MD、Wellspan Health
出版物と役立つリンク
一般刊行物
- 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.
- Gallaher JR, Charles A. Acute Cholecystitis: A Review. JAMA. 2022 Mar 8;327(10):965-975. doi: 10.1001/jama.2022.2350.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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