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

NCT ID: NCT02958592

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-10-31

Brief Summary

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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

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Conditions

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Liver Tumor Hepatic Fibrosis

Keywords

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shear-wave elastography hepatic fibrosis liver tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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study group

patients with liver tumor intend to perform hepatectomy

two-dimensional shear-wave elastography (SWE)

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhongguo Zhou

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Minshan Chen

Role: STUDY_DIRECTOR

Sun Yat-sen University

References

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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.

Reference Type DERIVED
PMID: 28807448 (View on PubMed)

Other Identifiers

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2016-FXY-132

Identifier Type: -

Identifier Source: org_study_id