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

NCT02958592 | Completed

• 1 other identifier: 2016-FXY-132
• Study Type: observational
• Target: 121
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Tumor; Hepatic Fibrosis

Keywords

shear-wave elastography; hepatic fibrosis; liver tumor

Outcome Measures

Primary Outcomes (1)

• Stage of hepatic fibrosis

  compare the stage of hepatic fibrosis between SWE test with specimens after surgery

  within the first 7 days after surgery

Study Arms (1)

study group

patients with liver tumor intend to perform hepatectomy

Other: two-dimensional shear-wave elastography (SWE)

Interventions

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

study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with liver tumor intend to hepatectomy

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Related Publications (1)

• Huang Z, Zheng W, Zhang YJ, Xu L, Chen JB, Chen JC, Chen MS, Zhou Z. Assessing Hepatic Fibrosis Using 2-D Shear Wave Elastography in Patients with Liver Tumors: A Prospective Single-Center Study. Ultrasound Med Biol. 2017 Nov;43(11):2522-2529. doi: 10.1016/j.ultrasmedbio.2017.07.003. Epub 2017 Aug 12.

  PMID: 28807448 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Minshan Chen

  Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 5, 2016
• First Posted: November 8, 2016
• Study Start: June 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 8, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share