About this trial
Quality improvement study with prospective observational design. The study explores the feasibility of testing diagnostic accuracy of an emergency department-performed focused ultrasound scan of the popliteal fossa in detecting symptomatic Baker's cysts, and to evaluate the potential for such follow-ups to conserve radiological resources. Ultimately, this work aims to establish the feasibility and provide the foundational data necessary for a future definitive diagnostic accuracy study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Clinical signs and symptoms of DVT, prompting the treating physician to initiate d-Dimer or CCUS diagnostic strategies
Disqualifiers
Prior inclusion
FUP performed following d-Dimer or CCUS result already revealed
Trial population
Adult patients referred to the Emergency Department at Aarhus University Hospital with suspected deep vein thrombosis and undergoing diagnostic evaluation with D-dimer testing and/or complete compression ultrasound of the lower extremity will be included consecutively.
Trial design
Cohort
Prospective
Treatments tested in this trial
Index Test (Focused Ultrasound of the Popliteal Fossa)
Diagnostic testEligible patients will undergo a focused ultrasound examination of the popliteal fossa performed by a trained research assistant or emergency physician. The examination will be conducted before the results of D-dimer testing and CCUS are available. Operators will assess the presence and characteristics of Baker's cysts, evaluate whether an identified cyst is likely to explain the patient's presenting symptoms, estimate the probability of concurrent DVT, and complete a structured interpretation survey. FUP findings will be recorded for research purposes only and will not influence patient management.
Reference test (Routine DVT Diagnostic Pathway)
Diagnostic testFollowing FUP, all participants will proceed through the routine diagnostic pathway for suspected DVT. Depending on clinical probability and D-dimer results, patients may undergo no further testing or radiologist-performed complete compression ultrasound of the lower extremity (CCUS) according to standard practice. Final diagnoses established through the routine diagnostic pathway will serve as the reference standard.
Treatment groups
Trial outcomes
Primary outcomes
Participant recruitment rate
Number of eligible patients enrolled per study month and proportion of eligible patients successfully enrolled.
Secondary outcomes
Completion rate of Focused Ultrasound of the Popliteal Fossa
Proportion of initiated FUP examinations successfully completed and deemed interpretable.
Duration of the FUP examination
Time required to perform and document the FUP examination.
Diagnostic accuracy of FUP for detection of symptomatic Baker's cysts
Sensitivity, specificity, positive predictive value, and negative predictive value of FUP compared with radiologist-performed complete compression ultrasound of the lower extremity (CCUS).
Frequency of symptomatic Baker's cysts among patients evaluated for suspected DVT.
Proportion of participants with a symptomatic Baker's cyst identified on FUP.
Sponsors and contacts
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