Preoperative Estimation of Microvascular Invasion in Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Nomogram for Preoperative Estimation of Microvascular Invasion Risk in Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Diagnostic Test: contrast-enhanced ultrasound
* Diagnostic Test: contrast-enhanced computed tomography


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preoperative clinical/imaging features<br>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). | Diagnostic Test: contrast-enhanced ultrasound<br>* The Aplio SSA-770A or Aplio 500 (Toshiba Medical Systems, Tokyo, Japan) equipped with a 375BT convex transducer (frequency range, 1.9 to 6.0 MHz). CHI is used with a mechanical index that ranged from 0.06 to 0.10. After activating CHI mode, a bolus injection of 2.4 ml of SonoVue (Bracco, Milan, Italy) is administered intravenously via an antecubital vein, followed immediately by a flush of 5 ml of normal saline solution. The targeted lesion should be observed continuously for 5 minutes, and the entire arterial and portal venous phases and several repetitions of the late phase are stored on the hard disk. The arterial, portal venous and late phases are defined as 0-30 s, 31-120 s and 121-360 s after the injection, respectively.<br>Diagnostic Test: contrast-enhanced computed tomography<br>* The Aquilion 64-slice helical CT machine (Tokyo, Japan) is used. The imaging protocol for CT examinations is as follows: 0.5 mm × 64 mm collimation, 120 kV, 150-200 mAs for 64-slice helical CT examination. The standard triphasic scan procedure is used. An unenhanced helical sequence scan through the liver will be performed first; thereafter nonionic iodinated contrast material (Ultravist, Schering, Berlin, Germany) (1.5 mL/kg) will be administered via antecubital vein with power injection at a rate of 4 mL/s for 64-slice helical CT. The arterial phase sequence is obtained 25-32 s after contrast material administration, followed by a portal venous phase sequence 70 s after contrast agent administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of microvascular invasion | Postoperative histologically confirmed microvascular invasion | Through patient enrollment completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microvascular invasion, serum biomarker, radiological feature, pathological differentiation