Assessment of Hepatic Fibrosis by Shear Wave Elastography in Patients With Liver Malignancy: A Prospective Single-center Study

Overview

To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection, using resected tissue pathology as a reference standard.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2016

Interventions

  • Other: two-dimensional shear-wave elastography (SWE)
    • performa two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection

Arms, Groups and Cohorts

  • study group
    • patients with liver tumor intend to perform hepatectomy

Clinical Trial Outcome Measures

Primary Measures

  • Stage of hepatic fibrosis
    • Time Frame: within the first 7 days after surgery
    • compare the stage of hepatic fibrosis between SWE test with specimens after surgery

Participating in This Clinical Trial

Inclusion Criteria

  • (i) patients with a solid focal liver lesion that was pathologically proven or diagnosed by imaging methods such as conventional US, CT or MR imaging; (ii) patients scheduled to undergo a hepatectomy; (iii) patients with a lesion ≥1.0 cm in diameter. Exclusion Criteria:

  • (i) patients with a history of chemotherapy; (ii) patients unable to properly hold their breath.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhongguo Zhou, Doctor – Sun Yat-sen University
  • Overall Official(s)
    • Minshan Chen, Study Director, Sun Yat-sen University

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