Preoperative Estimation of Microvascular Invasion in Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Nomogram for Preoperative Estimation of Microvascular Invasion Risk in Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03110068
• Other study ID #: SYSU01-US-201701
• Status: Not yet recruiting
• Phase: N/A
• First received: March 30, 2017
• Last updated: April 6, 2017
• Start date: April 10, 2017
• Est. completion date: April 15, 2019

Study information

• Verified date: April 2017
• Source: Sun Yat-sen University
• Contact: Wei Wang, MD, PhD
• Phone: +86 18218227118
• Email: wangw73[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 370
• Est. completion date: April 15, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• contrast-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.
• contrast-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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ming Kuang

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of microvascular invasion	Postoperative histologically confirmed microvascular invasion	Through patient enrollment completion, an average of 2 years