The First Hospital of Jilin University
Changchun, Jilin, 130000, China
NCT Number: NCT07579533
Objective: To compare the detection efficacy of standing, supine, and left lateral decubitus ultrasonographic scanning for space-occupying lesions ≤3cm in the liver dome "blind area" and assess the feasibility of standing position as a routine scanning posture, providing a theoretical basis for optimizing liver ultrasound protocols.
Methods: Prospectively enrolled patients (CT/MRI-confirmed liver dome lesions) admitted to our Hepatobiliary-Pancreatic Department (Feb 2024-Feb 2025). Three sonographers, blinded to other positions' results, performed scans in standing, supine, and left lateral positions. Fleiss' kappa assessed inter-sonographer agreement. An image quality scoring system (0=not visible; 1=partially visible; 2=fully visible) was used by two blinded radiologists. Baseline data (sex, age, BMI), lesion location, size, type, and liver parenchymal status (normal, fatty liver, liver damage [diffuse disease/cirrhosis]) were recorded. Wilcoxon test compared display scores. Subgroup analyses evaluated confounding factors. A Generalized Estimating Equations (GEE) model controlled repeated-measures bias, reporting ORs.
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Observational
Changchun, Jilin, 130000, China
Patient Collection:
Enroll patients hospitalized in our Hepatobiliary-Pancreatic Department between February 2024 and February 2025 with subphrenic liver lesions confirmed by CT or MRI. These patients underwent ultrasound examinations. Collect and record demographic data (sex, age, height, weight, BMI) and lesion characteristics (size, location, type, liver background).
Inclusion & Exclusion Criteria
Inclusion criteria
Exclusion criteria
Equipment & Methods
Equipment:
GE LOGIQ-E9 ultrasound system with C1-6-D low-frequency convex probe.
Procedure:
Ultrasound Image Acquisition:
Three sonographers (>3 years' experience) randomly selected one position per patient. Scanning included intercostal/subcostal approaches. Patients cooperated with breathing/positioning. If a lesion was detected, the clearest image was saved; if not, no image was captured. Sonographers were blinded to lesion presence and prior CT/MRI results. Each sonographer left the room after scanning their assigned position.
Image Quality Evaluation:
Evaluation:
Two blinded radiologists (>3 years' experience) independently scored lesion visibility. Discrepancies were resolved by re-evaluation and consensus. Evaluators were blinded to patient position.
Scoring System:
Sonographer Consistency Test:
20 randomly selected patients were re-scanned by all three sonographers across all positions. Each sonographer recorded lesion detectability per position.
Bias Control:
Selection Bias: Consecutive enrollment of eligible patients. Sonographer Bias: Blinded scanning; no prior knowledge of CT/MRI/history; Fleiss' kappa for inter-operator consistency.
Reader Bias: Independent blinded scoring with consensus for discrepancies.
Quality Control:
Strict adherence to protocol; trained/certified personnel; standardized data collection/entry/analysis; complete records; predefined statistical methods; unbiased reporting.
Statistical Analysis:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: The time from discovery of the space-occupying lesion to image acquisition was less than six months
Two ultrasound physicians, each with over three years of experience, independently evaluated the visibility of space-occupying lesions in the acquired images. If their initial assessments differed, they re-evaluated the images and reached a consensus through discussion. Both physicians were blinded to the patient's scanning position during evaluation.
Scoring Criteria:
A three-point scoring system was used to assess the visibility of lesions near the diaphragmatic dome (refer to Figures 2.2 and 2.3 for examples):
Score 2 (Fully Visible): The space-occupying lesion is clearly visualized without obscuration by gas or ribs. Margins are complete, and lesion size can be accurately measured.
Score 1 (Partially Visible): The space-occupying lesion is visualized suboptimally, obscured by gas or ribs. Margins are incomplete, and lesion size cannot be accurately measured.
Score 0 (Not Visible): The space-occupying lesion is completely undetectable.
The First Hospital of Jilin University
Other
Study on the Imaging Efficacy of Standing Position Ultrasonography in Detecting Lesions Within the Blind Area Near the Diaphragmatic Dome of the Liver
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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