이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 5월 5일 업데이트: 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.

연구 개요

상태

완전한

상세 설명

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.

연구 유형

관찰

등록 (실제)

95

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Jilin
      • Changchun, Jilin, 중국, 130000
        • The First Hospital of Jilin University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

확률 샘플

연구 인구

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).

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Evaluation of Image Display Effects Under Three Body Positions
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 2월 1일

기본 완료 (실제)

2025년 2월 1일

연구 완료 (실제)

2025년 7월 1일

연구 등록 날짜

최초 제출

2026년 5월 5일

QC 기준을 충족하는 최초 제출

2026년 5월 5일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 5일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다