Preoperative Estimation of Microvascular Invasion in Hepatocellular Carcinoma

• Conditions: Hepatocellular Carcinoma
• Interventions: Diagnostic Test: contrast-enhanced ultrasound; Diagnostic Test: contrast-enhanced computed tomography

• Registration Number: NCT03110068
• Lead Sponsor: Ming Kuang

Brief Summary

Presence of microvascular invasion can be estimated preoperatively, by some clinical imaging features such as patient characteristics, serum biomarkers and radiological features. Contrast-enhanced ultrasonography (CEUS) and contrast-enhanced computed tomography (CECT) are routine preoperative conventional examinations for hepatocellular carcinoma (HCC) patients in China. Combining features of CEUS, CECT and clinical factors may improve preoperative MVI assessment. The purpose of this study is to construct a nomogram for preoperative MVI risk estimation with these possible factors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-30
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-06
• Last Update Submitted: 2017-04-06
• Study Start: 2017-04-10
• Study First Posted: 2017-04-12
• Last Update Posted: 2017-04-12
• Primary Completion: 2019-04-10
• Study Completion: 2019-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

• Asian patients aged 18～80 years old;
• With no preoperative anti-cancer treatment;
• Scheduled for radical liver resection;
• With both CEUS and CECT performed in 4 weeks before surgery;
• Postoperative histologically confirmed HCC;
• With sufficient surgical specimen for MVI detection (surgical margin ≥1cm);

Exclusion Criteria

• Recurrent HCC or combined hepatocellular-cholangiocarcinoma;
• With extra-hepatic metastasis or macrovascular invasion;
• With incomplete clinical and imaging data;
• Non-radical resection;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preoperative clinical/imaging features	contrast-enhanced ultrasound	In this project, there is only one study group which comprises of patients with Hepatocellular Carcinoma (HCC) who will undergo contrast-enhanced computed tomography (CECT) and contrast-enhanced ultrasound (CEUS).
Preoperative clinical/imaging features	contrast-enhanced computed tomography	In this project, there is only one study group which comprises of patients with Hepatocellular Carcinoma (HCC) who will undergo contrast-enhanced computed tomography (CECT) and contrast-enhanced ultrasound (CEUS).

Primary Outcome Measures

Name	Time	Method
Presence of microvascular invasion	Through patient enrollment completion, an average of 2 years	Postoperative histologically confirmed microvascular invasion