Contrast-Enhanced Ultrasound for Early Assessment of Microwave Ablation in HCC (SBS-CEUS)
A Diagnostic Pilot Study of Side-by-Side Contrast-Enhanced Ultrasound for Early Assessment of Microwave Ablation Efficacy in Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the sixth most common malignancy and the fourth leading cause of cancer-related deaths worldwide [1]. Although surgical resection remains the reference curative therapy, ultrasound-guided microwave ablation (MWA) yields comparable oncologic outcomes [2,3] and is endorsed as a first-line option in several national and international guidelines. A sufficient ablative ablation margins (AM) is pivotal for preventing local tumour progression (LTP) [4,5].
According to current consensus, technical success is judged one month after ablation using contrast-enhanced CT (CE-CT) or MRI (CE-MRI) together with long-term follow-up [6,7]. Yet, inflammatory changes within the ablation zone peak during the first few days, delaying reliable evaluation, increasing patient anxiety, and often necessitating multiple imaging sessions.In recent years, various fusion imaging methods have been used to assess AM after ablation in HCC patients, including CT-CT image fusion [8, 9], MR-MR image fusion [10, 11], and contrast-enhanced ultrasound (CEUS)-CT/MR image fusion [12, 13]. However, fusion imaging techniques require high-quality preoperative images, and post-operative liver displacement and deformation due to tumour removal can make image registration difficult.
Contrast-enhanced ultrasound (CEUS) is widely used in clinical practice due to its economic simplicity, lack of radiation, and ability to display lesion areas in real time [14-16]. Recently, fusion imaging based on 3D CEUS has been reported to show good accuracy in AM evaluation [17-19], but the assessment of AM for multiple ablations of multiple tumours remains uncertain.Therefore, the potential of CEUS for early assessment of AM should be further developed. Simultaneous-screen comparison contrast-enhanced ultrasound (SBS-CEUS) refers to the simultaneous comparison of arterial phase images before and after tumour ablation under the same settings of the ultrasound diagnostic instrument.Studies have shown [20] that SBS-CEUS has significant value in displaying liver lesions in difficult-to-visualise areas, but to date, no studies have systematically compared SBS-CEUS with CEUS in the assessment of AM.
This retrospective study therefore compared the diagnostic accuracy of SBS-CEUS versus CEUS for early (1-3 days) assessment of the AM after MWA in patients with HCC.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Jilin
-
Changchun、Jilin、中国、130021
- GE
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
a) HCC diagnosed according to EASL guidelines and confirmed by pathology and/or typical imaging features on CE-CT, CE-MRI, or CEUS;b) ≤3 lesions, each ≤5 cm, without vascular/bile-duct invasion or distant metastasis;c) CE-MRI performed at our centre ≤1 month before and ≤1 month after ablation (CE-CT for MRI-contraindicated patients) to serve as the reference standard;d)Baseline CEUS ≤7 days before MWA and follow-up CEUS 1-3 days after MWA .
Exclusion Criteria:
a) Severe comorbid disease;b) Missing mandatory imaging;c) Any condition judged by the investigators to preclude reliable data acquisition.
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
- 主な目的:ふるい分け
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Side-by-Side Contrast-Enhanced Ultrasound for Early Assessment of Microwave Ablation Efficacy in HCC
Side-by-Side Contrast-Enhanced Ultrasound is performed 1-3 days after MWA surgery.
|
Side-by-Side Contrast-Enhanced Ultrasound is performed 1-3 days after MWA surgery, with contrast-enhanced MRI or CT one month after microwave ablation as the reference standard. Contrast-Enhanced Ultrasound is performed within 7 days before MWA surgery and 1-3 days after surgery, with contrast-enhanced MRI or CT one month after microwave ablation as the reference standard. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Side-by-Side Contrast-Enhanced Ultrasound and Contrast-Enhanced Ultrasound were used to evaluate the efficacy of microwave ablation for hepatocellular carcinoma. Based on the minimum distance between the tumour margin and the ablation zone, early postope
時間枠:Contrast-enhanced ultrasound (CEUS) was performed within 7 days prior to microwave ablation for hepatocellular carcinoma, and side-by-side contrast-enhanced ultrasound and contrast-enhanced ultrasound were performed simultaneously within 1-3 days after t
|
Contrast-enhanced ultrasound (CEUS) was performed within 7 days prior to microwave ablation for hepatocellular carcinoma, and side-by-side contrast-enhanced ultrasound and contrast-enhanced ultrasound were performed simultaneously within 1-3 days after t
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2023-KS-233
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?
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
米国で製造され、米国から輸出された製品。
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。
肝細胞がん(HCC)の臨床試験
-
Guangzhou Virotech Pharmaceutical Co., Ltd.募集
-
University of PisaAzienda Ospedaliera Città della Salute e della Scienza di Torino; Fondazione Policlinico Universitario... と他の協力者募集
-
Huazhong University of Science and Technologyわからない
-
Leiden University Medical CenterMedtronic; ZonMw: The Netherlands Organisation for Health Research and Development; Maag Lever... と他の協力者完了