Standing Position Ultrasonography: Imaging Efficacy in Detecting Liver Diaphragmatic Dome Blind Area Lesions

NCT07579533 | Completed

• 1 other identifier: 2024-HS-125
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Liver Tumours; Ultrasound; Position

Keywords

Liver Tumours; Ultrasound; Position

Outcome Measures

Primary Outcomes (1)

• 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.

  The time from discovery of the space-occupying lesion to image acquisition was less than six months

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• Inability to cooperate with three-position ultrasound examination;
• Subcutaneous emphysema affecting ultrasound;
• Chilaiditi syndrome (interposition of colon).

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PI

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)