Focused Ultrasound of the Popliteal Fossa for Detection of Symptomatic Baker's Cysts in Patients With Suspected Deep Vein Thrombosis: A Pilot Diagnostic Accuracy Study (BAKER-DVT)
Focused Ultrasound of the Popliteal Fossa for Detection of Symptomatic Baker's Cysts in Patients With Suspected Deep Vein Thrombosis: A Feasibility Diagnostic Accuracy Study
Study Overview
Status
Conditions
Detailed Description
Patients with suspected deep vein thrombosis (DVT) are commonly evaluated using clinical probability assessment, D-dimer testing, and compression ultrasonography. However, a substantial proportion of patients referred for DVT evaluation are ultimately diagnosed with alternative conditions that may explain their symptoms. One such condition is a symptomatic Baker's cyst, which may present with unilateral leg pain, swelling, or discomfort that clinically mimics DVT.
In current clinical practice, radiologist-performed complete compression ultrasound of the lower extremity (CCUS) is primarily used to confirm or exclude DVT. Although Baker's cysts are frequently identified during these examinations, their potential role as an early alternative diagnosis within the diagnostic pathway has not been systematically investigated. A focused ultrasound examination of the popliteal fossa (FUP) may allow emergency department (ED) or primary care clinicians to identify symptomatic Baker's cysts before referral for further DVT workup.
This prospective pilot study primarily aims to evaluate the feasibility of conducting a future definitive study investigating the role of FUP in patients with suspected DVT. Key feasibility outcomes include recruitment rates, scan completion rates, workflow integration, procedure timing, and practical implementation within routine emergency care. In addition, the study will generate preliminary diagnostic accuracy estimates regarding the ability of ED physicians and trained research assistants to identify symptomatic Baker's cysts using FUP, with CCUS serving as the reference standard. These data will be used to estimate outcome variance and inform sample size calculations and study design for a future definitive validation study.
This single-center pilot study will be conducted at Aarhus University Hospital, Denmark, among adult patients referred to the ED with suspected DVT. All participants will receive standard diagnostic evaluation and management according to current guidelines. The study-specific FUP examination will be performed before D-dimer and/or CCUS results are available, and FUP findings will not influence clinical decision-making during the study.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Aarhus, Denmark
- Recruiting
- Aarhus University Hospital
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Contact:
- Stig Holm Ovesen, MD, PhD
- Phone Number: 0045 + 29426696
- Email: stigje@rm.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- Clinical signs and symptoms of DVT, prompting the treating physician to initiate d-Dimer or CCUS diagnostic strategies
Exclusion Criteria:
- Prior inclusion
- FUP performed following d-Dimer or CCUS result already revealed
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients with suspected deep vein thrombosis (DVT)
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 (CCUS) will be included consecutively.
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Eligible 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.
Following 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Participant recruitment rate
Time Frame: Immediately after the procedure
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Number of eligible patients enrolled per study month and proportion of eligible patients successfully enrolled.
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Immediately after the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Completion rate of Focused Ultrasound of the Popliteal Fossa
Time Frame: Immediately after the procedure
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Proportion of initiated FUP examinations successfully completed and deemed interpretable.
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Immediately after the procedure
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Duration of the FUP examination
Time Frame: Immediately after the procedure
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Time required to perform and document the FUP examination.
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Immediately after the procedure
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Diagnostic accuracy of FUP for detection of symptomatic Baker's cysts
Time Frame: Immediately after the procedure
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Sensitivity, specificity, positive predictive value, and negative predictive value of FUP compared with radiologist-performed complete compression ultrasound of the lower extremity (CCUS).
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Immediately after the procedure
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Frequency of symptomatic Baker's cysts among patients evaluated for suspected DVT.
Time Frame: Immediately after the procedure
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Proportion of participants with a symptomatic Baker's cyst identified on FUP.
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Immediately after the procedure
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Concurrent DVT in participants with a symptomatic Baker's cyst identified on FUP
Time Frame: Immediately after the procedure
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Proportion of participants with a symptomatic Baker's cyst on FUP who are subsequently diagnosed with DVT through the routine diagnostic pathway.
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Immediately after the procedure
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Estimated impact of FUP on clinical decision-making
Time Frame: Immediately after the procedure
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Proportion of examinations in which the operator indicates that the FUP finding would have altered the estimated post-test probability of DVT or influenced further diagnostic workup.
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Immediately after the procedure
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Ultrasound image quality
Time Frame: Within 60 days of the index examination
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Proportion of FUP examinations rated as of adequate diagnostic quality upon retrospective review by a proficient radiologist.
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Within 60 days of the index examination
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Baker's Cysts in DVT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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