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NCT02958592 Clinical Trial

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

Liver Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02958592
Other study ID # 2016-FXY-132
Secondary ID
Status Completed
Phase N/A
First received November 5, 2016
Last updated November 5, 2016
Start date June 2015
Est. completion date October 2016

Study information
Verified date November 2016
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority China: Health and Family Planning Commission of Guangdong Province
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 121
Est. completion date October 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Outcome
Type Measure Description Time frame Safety issue
Primary Stage of hepatic fibrosis compare the stage of hepatic fibrosis between SWE test with specimens after surgery within the first 7 days after surgery No
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