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

Completed

• Conditions: Liver Tumor; Hepatic Fibrosis
• Interventions: Other: two-dimensional shear-wave elastography (SWE)

• Registration Number: NCT02958592
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2016-03
• Study Completion: 2016-10
• Status Verified: 2016-11
• Study First Submitted: 2016-11-05
• Study First Submitted QC: 2016-11-05
• Last Update Submitted: 2016-11-05
• Study First Posted: 2016-11-08
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	two-dimensional shear-wave elastography (SWE)	patients with liver tumor intend to perform hepatectomy

Primary Outcome Measures

Name	Time	Method
Stage of hepatic fibrosis	within the first 7 days after surgery	compare the stage of hepatic fibrosis between SWE test with specimens after surgery