Liver TumoursNCT07579533
Standing Position Ultrasonography: Imaging Efficacy in Detecting Liver Diaphragmatic Dome Blind Area Lesions
An observational study of Liver Tumours and Ultrasound, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Tumours, Ultrasound, Position
- Type of treatment
- Injection or infusion
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Jul 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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).
Who may be able to join
- Liver dome lesions (≤3 cm) confirmed by CT/MRI (plain + enhanced) within 6 months (for multiple lesions, include the one closest to the diaphragm);
- Superior border of lesion ≤1 cm from the diaphragm;
- Lesion size ≤3 cm.
Who cannot join
- Inability to cooperate with three-position ultrasound examination;
- Subcutaneous emphysema affecting ultrasound;
- Chilaiditi syndrome (interposition of colon).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Imaging Efficacy of Standing Position Ultrasonography in Detecting Lesions Within the Blind Area Near the Diaphragmatic Dome of the Liver
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.
Read the detailed description
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:
- Liver dome lesions (≤3 cm) confirmed by CT/MRI (plain + enhanced) within 6 months (for multiple lesions, include the one closest to the diaphragm);
- Superior border of lesion ≤1 cm from the diaphragm;
- Lesion size ≤3 cm.
Exclusion Criteria:
- Inability to cooperate with three-position ultrasound examination;
- Subcutaneous emphysema affecting ultrasound;
- Chilaiditi syndrome (interposition of colon).
Equipment \& Methods
Equipment:
GE LOGIQ-E9 ultrasound system with C1-6-D low-frequency convex probe.
Procedure:
- Patients fasted for 2-3 hours and rested for 10-20 minutes before examination.
- Three scanning positions (Fig 2.1):
- Supine: Arms raised above head, fully exposing intercostal/subcostal areas; back parallel to bed.
- Left Lateral Decubitus: Arms raised, fully exposed intercostal/subcostal areas; side-facing away from examiner; back perpendicular to bed.
- Standing: Arms raised, fully exposed intercostal/subcostal areas; upright with body axis vertical to floor.
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:
- 2 = Fully visible: Clear lesion without gas/bone shadowing; complete margins; measurable size.
- 1 = Partially visible: Suboptimal visualization; obscured by gas/bone; incomplete margins; unmeasurable size.
- 0 = Not visible: Undetectable.
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:
- SPSS 26.0 software. Fleiss' kappa assessed inter-sonographer agreement. Normally distributed data: mean±SD; non-normal: median (IQR). Friedman test compared scores across positions; Wilcoxon signed-rank test for pairwise comparisons. Significance: P<0.05.
- Subgroup Analysis: Stratified by BMI (normal/underweight, overweight/obese), liver background (normal, fatty liver, liver damage [diffuse disease/cirrhosis]), lesion location (S4, S7, S8), size (0-1 cm, 1.1-2.0 cm, 2.1-3.0 cm), and type (HCC, non-HCC). Non-parametric tests repeated per subgroup.
- Generalized Estimating Equations (GEE): Binary logistic model (patient ID as subject variable; outcome: complete visibility) with exchangeable working correlation matrix. Covariates: position (supine as reference), location (S8 as reference), liver background, lesion type, size, and BMI. Results: OR (95% CI). Sensitivity analysis compared exchangeable, AR1, and unstructured correlation matrices.
- Conditions
- Liver Tumours, Ultrasound, Position
- Keywords
- Liver Tumours, Ultrasound, Position
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Three scanning positions | Inclusion Criteria: 1. Liver dome lesions (≤3 cm) confirmed by CT/MRI (plain + enhanced) within 6 months (for multiple lesions, include the one closest to the diaphragm); 2. Superior border of lesion ≤1 cm from the diaphragm; 3. Lesion size ≤3 cm. Exclusion Criteria: 1. Inability to cooperate with three-position ultrasound examination; 2. Subcutaneous emphysema affecting ultrasound; 3. Chilaiditi syndrome (interposition of colon). Equipment: GE LOGIQ-E9 ultrasound system with C1-6-D low-frequency convex probe. Procedure: 1. Patients fasted for 2-3 hours and rested for 10-20 minutes before examination. 2. Three scanning positions : Supine: Arms raised above head, fully exposing intercostal/subcostal areas; back parallel to bed. Left Lateral Decubitus: Arms raised, fully exposed intercostal/subcostal areas; side-facing away from examiner; back perpendicular to bed. Standing: Arms raised, fully exposed intercostal/subcostal areas; upright with body axis vertical to floor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Image Display Effects Under Three Body Positions
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.
Measured: The time from discovery of the space-occupying lesion to image acquisition was less than six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Feb 2024
- Primary completion1 Feb 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumoursStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dezhi Zhang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579533
- Sponsor's protocol ID
- 2024-HS-125
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Imaging Efficacy of Standing Position Ultrasonography in Detecting Lesions Within the Blind Area Near the Diaphragmatic Dome of the Liver
- ClinicalTrials.gov ID
- NCT07579533
- Acronym / sponsor ID
- 2024-HS-125
- Conditions
- Liver Tumours, Ultrasound, Position
- Keywords
- Liver Tumours, Ultrasound, Position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Liver dome lesions (≤3 cm) confirmed by CT/MRI (plain + enhanced) within 6 months (for multiple lesions, include the one closest to the diaphragm);
- Superior border of lesion ≤1 cm from the diaphragm;
- Lesion size ≤3 cm.
Exclusion Criteria:
- Inability to cooperate with three-position ultrasound examination;
- Subcutaneous emphysema affecting ultrasound;
- Chilaiditi syndrome (interposition of colon).
Equipment \& Methods
Equipment:
GE LOGIQ-E9 ultrasound system with C1-6-D low-frequency convex probe.
Procedure:
- Patients fasted for 2-3 hours and rested for 10-20 minutes before examination.
- Three scanning positions (Fig 2.1):
- Supine: Arms raised above head, fully exposing intercostal/subcostal areas; back parallel to bed.
- Left Lateral Decubitus: Arms raised, fully exposed intercostal/subcostal areas; side-facing away from examiner; back perpendicular to bed.
- Standing: Arms raised, fully exposed intercostal/subcostal areas; upright with body axis vertical to floor.
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:
- 2 = Fully visible: Clear lesion without gas/bone shadowing; complete margins; measurable size.
- 1 = Partially visible: Suboptimal visualization; obscured by gas/bone; incomplete margins; unmeasurable size.
- 0 = Not visible: Undetectable.
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:
- SPSS 26.0 software. Fleiss' kappa assessed inter-sonographer agreement. Normally distributed data: mean±SD; non-normal: median (IQR). Friedman test compared scores across positions; Wilcoxon signed-rank test for pairwise comparisons. Significance: P<0.05.
- Subgroup Analysis: Stratified by BMI (normal/underweight, overweight/obese), liver background (normal, fatty liver, liver damage [diffuse disease/cirrhosis]), lesion location (S4, S7, S8), size (0-1 cm, 1.1-2.0 cm, 2.1-3.0 cm), and type (HCC, non-HCC). Non-parametric tests repeated per subgroup.
- Generalized Estimating Equations (GEE): Binary logistic model (patient ID as subject variable; outcome: complete visibility) with exchangeable working correlation matrix. Covariates: position (supine as reference), location (S8 as reference), liver background, lesion type, size, and BMI. Results: OR (95% CI). Sensitivity analysis compared exchangeable, AR1, and unstructured correlation matrices.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three scanning positions | – | –Inclusion Criteria: 1. Liver dome lesions (≤3 cm) confirmed by CT/MRI (plain + enhanced) within 6 months (for multiple lesions, include the one closest to the diaphragm); 2. Superior border of lesion ≤1 cm from the diaphragm; 3. Lesion size ≤3 cm. Exclusion Criteria: 1. Inability to cooperate with three-position ultrasound examination; 2. Subcutaneous emphysema affecting ultrasound; 3. Chilaiditi syndrome (interposition of colon). Equipment: GE LOGIQ-E9 ultrasound system with C1-6-D low-frequency convex probe. Procedure: 1. Patients fasted for 2-3 hours and rested for 10-20 minutes before examination. 2. Three scanning positions : Supine: Arms raised above head, fully exposing intercostal/subcostal areas; back parallel to bed. Left Lateral Decubitus: Arms raised, fully exposed intercostal/subcostal areas; side-facing away from examiner; back perpendicular to bed. Standing: Arms raised, fully exposed intercostal/subcostal areas; upright with body axis vertical to floor. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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).
Key inclusion criteria (3 listed)
- Liver dome lesions (≤3 cm) confirmed by CT/MRI (plain + enhanced) within 6 months (for multiple lesions, include the one closest to the diaphragm);
- Superior border of lesion ≤1 cm from the diaphragm;
- Lesion size ≤3 cm.
Key exclusion criteria (3 listed)
- Inability to cooperate with three-position ultrasound examination;
- Subcutaneous emphysema affecting ultrasound;
- Chilaiditi syndrome (interposition of colon).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of Image Display Effects Under Three Body Positions
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Tumours and Ultrasound, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Image Display Effects Under Three Body Positions (time frame: The time from discovery of the space-occupying lesion to image acquisition was less than six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.