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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Brent Becker Principal Investigator, MD
- 전화번호: 717-851-4819
- 이메일: bbecker2@wellspan.org
연구 연락처 백업
- 이름: Kristen Wilhelm Research Coordinator, MS
- 전화번호: 717-812-5075
- 이메일: kwilhelm6@wellspan.org
연구 장소
-
-
Pennsylvania
-
York, Pennsylvania, 미국, 17403
- 모병
- WellSpan Health York Hospital
-
연락하다:
- Brent Becker, MD
- 전화번호: 717-851-4819
- 이메일: bbecker2@wellspan.org
-
연락하다:
- Kristen Wilhelm, MS
- 전화번호: 717-812-5075
- 이메일: kwilhelm6@wellspan.org
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of patients diagnosed with acute cholecystitis
기간: Within 30 days of enrollment
|
Diagnosis of acute cholecystitis
|
Within 30 days of enrollment
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Interval change in gallbladder wall thickness (GWT) on repeat biliary point-of-care ultrasound
기간: 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
기간: 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))
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Within 30 days of enrollment
|
Need for cholecystectomy, cholecystostomy tube, endoscopic retrograde cholangiopancreatography or other procedural biliary intervention
|
Within 30 days of enrollment
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Brent Becker, MD, Wellspan Health
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2443255
개별 참가자 데이터(IPD) 계획
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