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

2026年5月5日 更新者:Dezhi Zhang、The First Hospital of Jilin University

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.

研究概览

地位

完全的

详细说明

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:

  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 & Methods

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 (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:

  1. 2 = Fully visible: Clear lesion without gas/bone shadowing; complete margins; measurable size.
  2. 1 = Partially visible: Suboptimal visualization; obscured by gas/bone; incomplete margins; unmeasurable size.
  3. 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:

  1. 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.
  2. 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.
  3. 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.

研究类型

观察性的

注册 (实际的)

95

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Jilin
      • Changchun、Jilin、中国、130000
        • The First Hospital of Jilin University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

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).

描述

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).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Evaluation of Image Display Effects Under Three Body Positions
大体时间: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 time from discovery of the space-occupying lesion to image acquisition was less than six months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年2月1日

初级完成 (实际的)

2025年2月1日

研究完成 (实际的)

2025年7月1日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年5月5日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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