Clinical trial NCT03110068: Preoperative Estimation of Microvascular Invasion in Hepatocellular Carcinoma
Official title: Nomogram for Preoperative Estimation of Microvascular Invasion Risk in Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: microvascular invasion
serum biomarker
radiological feature
pathological differentiation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Presence of microvascular invasion
timeFrame: Through patient enrollment completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medical Ultrasonics, Institute of Diagnostic and Interventional Ultrasound, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
name: Ming Kuang, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.