Contrast-Enhanced Ultrasound for Early Assessment of Microwave Ablation in HCC (SBS-CEUS)

May 13, 2026 updated by: Dezhi Zhang, The First Hospital of Jilin University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • GE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Side-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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 postope
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-KS-233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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