リンパ浮腫と脂肪腫の鑑別のためのマルチモーダル超音波
リンパ浮腫、リポデマ、および健康対照群における下肢皮膚および皮下組織の定量的エコー性と弾性イメージングを用いた超音波評価：制御された臨床研究
The aim of this observational study is to evaluate the diagnostic value of multimodal ultrasonography in differentiating between lymphedema and lipedema. Differentiating these two chronic conditions based solely on clinical examination can be challenging due to overlapping symptoms. This study will utilize various non-invasive ultrasound techniques-including B-mode ultrasound, strain elastography, power Doppler, and quantitative ImageJ analysis-to compare tissue characteristics among patients with lymphedema, patients with lipedema, and healthy controls. The goal is to identify reliable, non-invasive imaging biomarkers that can facilitate early and accurate diagnosis, thereby optimizing patient management.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Lymphedema and lipedema are distinct pathological entities that often present with similar clinical features, particularly in the lower extremities. Accurate differential diagnosis is crucial for appropriate therapeutic intervention. While modalities like lymphoscintigraphy serve as standard diagnostic tools for lymphedema, they are invasive and not universally accessible. High-resolution ultrasonography provides a practical, non-invasive alternative for tissue assessment.
This cross-sectional, observational study will recruit participants and categorize them into three groups: a lymphedema group, a lipedema group, and a healthy control group. Comprehensive multimodal ultrasound evaluations will be performed on all participants. The assessment protocol includes:
B-mode Ultrasonography: To measure the thickness of the dermis and subcutaneous tissue layers.
Strain Elastography: To evaluate the biomechanical properties and relative stiffness of the affected tissues.
Power Doppler: To assess the local microvascularity and blood flow patterns.
ImageJ Software Analysis: To perform quantitative pixel-based echogenicity evaluation of the ultrasound images.
By systematically comparing these ultrasonographic parameters across the three groups, this study aims to establish standard, reproducible imaging criteria. The primary objective is to determine which specific ultrasound modalities, or combinations thereof, offer the highest diagnostic accuracy in differentiating lymphedema from lipedema in clinical practice.
研究の種類
研究の種類
入学 (実際)
入学
連絡先と場所
研究場所
-
-
Kocasinan
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Kayseri、Kocasinan、トルコ（Türkiye）、38080
- Kayseri City Hospital
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
The study population consists of patients presenting to the Physical Medicine and Rehabilitation outpatient clinic with complaints of lower extremity swelling, diagnosed clinically with either lymphedema or lipedema. A healthy control group, matched for general demographic characteristics, will be recruited from volunteers without any lower extremity pathologies.
説明
Inclusion Criteria:
Individuals aged 18 to 65 years.
Clinical diagnosis of lower extremity lymphedema (for the lymphedema group).
Clinical diagnosis of lower extremity lipedema (for the lipedema group).
Healthy individuals with no history or clinical signs of chronic lower extremity edema (for the control group).
Exclusion Criteria:
Presence of active local infections, such as cellulitis or erysipelas, in the lower extremities.
History of deep vein thrombosis (DVT) or severe chronic venous insufficiency.
Systemic conditions that can cause secondary edema, including congestive heart failure, chronic kidney disease, or severe hepatic impairment.
Previous surgical interventions on the affected lower extremities, including liposuction, lymphatic reconstructive surgery, or major orthopedic surgeries.
Active malignancy or currently undergoing radiotherapy/chemotherapy.
Pregnancy or lactation.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_CONTROL
- 時間の展望：PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
Lymphedema Group
Patients clinically diagnosed with lower extremity lymphedema. Participants in this group will undergo a non-invasive multimodal ultrasound assessment (including B-mode, strain elastography, power Doppler, and ImageJ analysis) to evaluate tissue characteristics. |
A comprehensive, non-invasive ultrasonographic evaluation of the lower extremities. The protocol includes B-mode ultrasound for measuring dermis and subcutaneous tissue thickness, strain elastography for assessing tissue biomechanical stiffness, and Power Doppler for evaluating local microvascularity. Additionally, quantitative echogenicity of the tissues will be analyzed using ImageJ software.
他の名前：
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Lipedema Group
Patients clinically diagnosed with lipedema of the lower extremities. Participants in this group will undergo the identical non-invasive multimodal ultrasound assessment protocol to evaluate tissue echogenicity, thickness, and stiffness. |
A comprehensive, non-invasive ultrasonographic evaluation of the lower extremities. The protocol includes B-mode ultrasound for measuring dermis and subcutaneous tissue thickness, strain elastography for assessing tissue biomechanical stiffness, and Power Doppler for evaluating local microvascularity. Additionally, quantitative echogenicity of the tissues will be analyzed using ImageJ software.
他の名前：
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Healthy Control Group
Healthy volunteers with no history or clinical signs of chronic lower extremity edema, lymphedema, or lipedema. This group will undergo the same multimodal ultrasound assessment to establish baseline normative values for comparison. |
A comprehensive, non-invasive ultrasonographic evaluation of the lower extremities. The protocol includes B-mode ultrasound for measuring dermis and subcutaneous tissue thickness, strain elastography for assessing tissue biomechanical stiffness, and Power Doppler for evaluating local microvascularity. Additionally, quantitative echogenicity of the tissues will be analyzed using ImageJ software.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Dermal and Subcutaneous Tissue Thickness
時間枠：Day 1 (At the time of ultrasound assessment)
|
Measurement of the dermal and subcutaneous tissue layers in millimeters (mm) using high-resolution B-mode ultrasonography to identify anatomical differences between the groups. |
Day 1 (At the time of ultrasound assessment)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tissue Stiffness Assessment via Strain Elastography
時間枠：Day 1 (At the time of ultrasound assessment)
|
Evaluation of the biomechanical properties and relative stiffness of the subcutaneous tissue, assessed through color-coded elastogram scoring maps. |
Day 1 (At the time of ultrasound assessment)
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Quantitative Echogenicity Analysis
時間枠：Day 1 (At the time of ultrasound assessment)
|
Pixel-based quantitative evaluation of tissue echogenicity from ultrasound images, analyzed using ImageJ software to establish objective imaging biomarkers. |
Day 1 (At the time of ultrasound assessment)
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Visual Analogue Scale (VAS) for Pain
時間枠：Day 1 (Baseline clinical evaluation)
|
Assessment of the intensity of lower extremity pain reported by the participants on a scale from 0 (no pain) to 10 (worst imaginable pain). |
Day 1 (Baseline clinical evaluation)
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Mortimer PS, Rockson SG. New developments in clinical aspects of lymphatic disease. J Clin Invest. 2014 Mar;124(3):915-21. doi: 10.1172/JCI71608. Epub 2014 Mar 3.
- Gerard N, Farmakis IT, Valerio L, Hobohm L, Keller K, Kucher N, Barco S, Grigorean A. Epidemiological Study of Lymphedema Prevalence and Comorbidities in Hospitalized Patients in the United States. J Clin Med. 2025 Nov 17;14(22):8156. doi: 10.3390/jcm14228156.
- Rockson SG. Lymphedema. Am J Med. 2001 Mar;110(4):288-95. doi: 10.1016/s0002-9343(00)00727-0.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 2025-564
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data (IPD) will not be shared publicly to maintain participant confidentiality and in accordance with the policies of the institutional ethics committee. However, the study protocol and statistical analysis plan may be available upon reasonable request to the principal investigator.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。