Diagnosis of Nodules ≤2 cm Based on US and CEUS Compared With Current Clinical Procedure

Summary

Due to different etiologies, diagnosis and treatment of HCC in China is different from that in Western countries.US is an important screening method for HCC in patients with liver cirrhosis. CEUS, as an enhanced imaging method based on US, has the advantages of convenience, non-radiation, low cost, short examination time, and the diagnostic performance of HCC is comparable to that of CECT, CEMRI, and hepatobiliary-specific MRI.

It is of great significance to consider the cost-effectiveness of each examination based on the principle of cost minimization. Therefore, we propose immediate CEUS examination for suspicious lesions ≤2 cm screened by US, and determine the diagnostic process of further diagnostic methods based on the CEUS results. The aim of this study is to establish a screening and diagnosis process for HCC ≤2 cm suitable for China considering time effect, economic effect and diagnostic efficiency.

Conditions

• Liver Cancer
• Liver Cirrhosis

Interventions

DIAGNOSTIC_TEST

Immediate CEUS

Subjects will receive CEUS examination immediately for the suspicious lesion detected by US.

Sponsors & Collaborators

• Tianjin Second People's Hospital

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Peking University Binhai Hospital

  collaborator UNKNOWN

• Tianjin Nankai Hospital

  collaborator OTHER

• Tianjin Medical University Second Hospital

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Shanxi Province Cancer Hospital

  collaborator OTHER

• Shanxi Provincial People's Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital of Shanxi Medical University

  collaborator OTHER

• Second Hospital of Shanxi Medical University

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Hebei General Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The Third Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Tianjin Third Central Hospital

  lead OTHER

Principal Investigators

• Xiang Jing, MD · Tianjin Third Central Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-26

Primary Completion

2024-01-01

Completion

2024-12-31

Countries

• China

Study Locations