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Preoperative Estimation of Microvascular Invasion in Hepatocellular Carcinoma

Nomogram for Preoperative Estimation of Microvascular Invasion Risk in Hepatocellular Carcinoma

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03110068
Enrollment
370
Registered
2017-04-12
Start date
2017-04-10
Completion date
2019-04-15
Last updated
2017-04-12

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

Conditions

Hepatocellular Carcinoma

Keywords

microvascular invasion, serum biomarker, radiological feature, pathological differentiation

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.

Interventions

DIAGNOSTIC_TESTcontrast-enhanced ultrasound

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.

DIAGNOSTIC_TESTcontrast-enhanced computed tomography

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.

Sponsors

Ming Kuang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Presence of microvascular invasionThrough patient enrollment completion, an average of 2 yearsPostoperative histologically confirmed microvascular invasion

Contacts

Primary ContactWei Wang, MD, PhD
wangw73@mail.sysu.edu.cn+86 18218227118
Backup ContactHang-Tong Hu, MD
huhangt@gmail.com+86 13580313297

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026