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

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.

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Key information

Conditions

Liver Tumor Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Fibrosis Hepatic Fibrosis Liver Cirrhosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

two-dimensional shear-wave elastography (SWE)

Other

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Nov 8, 2016
Registry last updated: Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed