NCT03110068

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

April 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

March 30, 2017

Last Update Submit

April 6, 2017

Conditions

Hepatocellular Carcinoma

Keywords

microvascular invasionserum biomarkerradiological featurepathological differentiation

Outcome Measures

Primary Outcomes (1)

  • Presence of microvascular invasion

    Postoperative histologically confirmed microvascular invasion

    Through patient enrollment completion, an average of 2 years

Study Arms (1)

Preoperative clinical/imaging features

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 ultrasoundDiagnostic Test: contrast-enhanced computed tomography

Interventions

contrast-enhanced ultrasoundDIAGNOSTIC_TEST

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.

Preoperative clinical/imaging features
contrast-enhanced computed tomographyDIAGNOSTIC_TEST

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.

Preoperative clinical/imaging features

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Between April 2017 and April 2019，all consecutive patients who will undergo curative resection (R0 resection) at the First Affiliated Hospital of Sun Yat-Sen University in Guangzhou, China, for HCC based on the modified WHO classification of tumors of the digestive system, are considered for inclusion. By the eligibility criteria stated below, MVI presentative rate is 30-42% in chinese HCC population as reported, and an estimated 400 patients will be needed for this study.

You may qualify if:

  • 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);

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Lei Z, Li J, Wu D, Xia Y, Wang Q, Si A, Wang K, Wan X, Lau WY, Wu M, Shen F. Nomogram for Preoperative Estimation of Microvascular Invasion Risk in Hepatitis B Virus-Related Hepatocellular Carcinoma Within the Milan Criteria. JAMA Surg. 2016 Apr;151(4):356-63. doi: 10.1001/jamasurg.2015.4257.

    PMID: 26579636BACKGROUND

  • Zhao H, Hua Y, Dai T, He J, Tang M, Fu X, Mao L, Jin H, Qiu Y. Development and validation of a novel predictive scoring model for microvascular invasion in patients with hepatocellular carcinoma. Eur J Radiol. 2017 Mar;88:32-40. doi: 10.1016/j.ejrad.2016.12.030. Epub 2016 Dec 27.

    PMID: 28189206BACKGROUND

  • Feng LH, Dong H, Lau WY, Yu H, Zhu YY, Zhao Y, Lin YX, Chen J, Wu MC, Cong WM. Novel microvascular invasion-based prognostic nomograms to predict survival outcomes in patients after R0 resection for hepatocellular carcinoma. J Cancer Res Clin Oncol. 2017 Feb;143(2):293-303. doi: 10.1007/s00432-016-2286-1. Epub 2016 Oct 14.

    PMID: 27743138BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Ming Kuang, PhD

    Department of Medical Ultrasonics, Institute of Diagnostic and Interventional Ultrasound, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.

    STUDY DIRECTOR

Central Study Contacts

Wei Wang, MD, PhD

CONTACT

+86 18218227118wangw73@mail.sysu.edu.cn

Hang-Tong Hu, MD

CONTACT

+86 13580313297huhangt@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 12, 2017

Study Start

April 10, 2017

Primary Completion

April 10, 2019

Study Completion

April 15, 2019

Last Updated

April 12, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share