Evaluate Patients With Chronic Hepatitis by Three-dimensional Force-controlled Ultrasound Measurement

NCT ID: NCT02784925

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-07-31

Brief Summary

Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness. However, pressing the transducer onto the skin with too much force will significantly reduce the subcutaneous adipose tissue thickness. In this study, a force controlled system combined with US transducer was used for 3D subcutaneous fat imaging and reconstruction.

Detailed Description

The diagnosis of fatty liver (steatosis) is made when fat in the liver exceeds 5-10% by weight. Fatty liver (FL) is commonly associated with alcohol or metabolic syndrome (diabetes, hypertension, obesity, and dyslipidemia), but can also be due to any one of many causes. Most people were detected from serum lipid abnormalities in the physical examination, and confirmed as the fatty liver disease by ultrasound imaging. In some previous studies, ultrasound was reported to provide an accurate and reliable measurement tool for the thickness measurements of subcutaneous adipose tissue. This method can overcome some limitations of the skinfold thickness measurements. Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness. However, pressing the transducer onto the skin with too much force will significantly reduce the subcutaneous adipose tissue thickness. In this study, a force controlled system combined with US transducer was used for 3D subcutaneous fat imaging and reconstruction. Finally, the correlations between body fat percentage and subcutaneous fat in steatosis patients have been investigated. The body fat percentage was determined by dual energy X-ray absorptiometry (DEXA, GE Lunar iDXA canner) and bioelectrical impedance analysis (BIA, Omron，HBF-370), and then, the correlation between body fat percentage and subcutaneous adipose tissue in normal and steatosis patients have been evaluated.

Conditions

Fatty Liver

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

fatty liver subjects

Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.

Group Type: OTHER

Ultrasound (US) B mode image

Intervention Type: DEVICE

Ultrasound (US) B mode image is an alternative method to measure tissue structure

and has proven to be an accurate technique to measure subcutaneous fat thickness.

Interventions

Ultrasound (US) B mode image

Ultrasound (US) B mode image is an alternative method to measure tissue structure

and has proven to be an accurate technique to measure subcutaneous fat thickness.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged between 20-65 adults who are confirmed have fatty liver by echo

Exclusion Criteria

• none

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: collaborator

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

N201603045

Identifier Type: -

Identifier Source: org_study_id