- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07598331
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Jilin
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Changchun, Jilin, Kina, 130021
- GE
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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
Tidsramme: 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
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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
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2023-KS-233
Plan for individuelle deltakerdata (IPD)
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