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Contrast-Enhanced Ultrasound for Early Assessment of Microwave Ablation in HCC

A Diagnostic Pilot Study of Side-by-Side Contrast-Enhanced Ultrasound for Early Assessment of Microwave Ablation Efficacy in Hepatocellular Carcinoma

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07598331
Acronym
SBS-CEUS
Enrollment
106
Registered
2026-05-20
Start date
2021-06-01
Completion date
2025-06-30
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma (HCC), Side-by-side Contrast-enhanced Ultrasound

Keywords

side-by-side contrast-enhanced ultrasound, hepatocellular carcinoma, microwave ablation, ablative margin, local tumour progression, contrast-enhanced ultrasound

Brief summary

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.

Interventions

PROCEDURESide-by-Side Contrast-Enhanced Ultrasound

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.

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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 postopeContrast-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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026