Evaluation of Liver Fibrosis With 2D-Shear Wave Elastography

NCT ID: NCT04759521

Last Updated: 2021-02-18

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

253 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-03

Study Completion Date

2020-12-18

Brief Summary

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The aims of this study are to evaluate liver fibrosis with two-dimensional (2D) shear wave elastography (SWE) technique in inactive hepatitis B surface antigen (HBsAg) carriers and patients with active chronic hepatitis B (CHB), with the help of a propagation map, compare this method with histopathological results in patients with CHB and determine the suitability of 2D-SWE for use instead of liver biopsy by evaluating fibrosis before and after treatment.

Detailed Description

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A total of 253 patients with CHB and inactive HBsAg carriers as well as a control group of 30 healthy individuals were included in the study between January 2019 and October 2020. Liver stiffness measurements with 2D-SWE, fibrosis-4 (FIB-4) and aspartate aminotransferase to platelet ratio index (APRI) scoring and additional liver biopsy in patients with CHB were performed in all cases with the help of the propagation map. Depending on the degree of fibrosis, liver stiffness was measured again at 24 and 48 weeks in patients who received antiviral therapy. Spearman rank correlation test was used for analysing correlation between variables, and receiver operating curve analysis was used to evaluate diagnostic performance in terms of fibrosis.

Conditions

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Chronic Hepatitis B Sonoelastography Fibrosis, Liver

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Inactive HBsAg carriers were patients with HBsAg positivity for more than 6 months

No interventions assigned to this group

Group 2

Patients diagnosed with chronic hepatitis B were patients with HBsAg positivity for more than 6 months

No interventions assigned to this group

Group 3

The control group was composed of healthy individuals who were not infected with hepatitis B virus and did not fit any exclusion criteria.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Being infected with the hepatitis B virus,
2. \> 18 years old
3. \< 64 years old

Exclusion Criteria

1. Co-infection with hepatitis C or D
2. Have chronic or acute fulminant liver disease
3. Have DM disease
4. Hypertriglyceridemia, obesity, grade2 and higher hepatosteatosis,
5. Long-term drug use, alcohol intake that may damage the liver
6. Under the age of eighteen
7. Over sixty-five years old
8. Transplantation patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seyhmus Kavak

OTHER

Sponsor Role lead

Responsible Party

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Seyhmus Kavak

MD, Radiologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sağlik Bilimleri Üniversitesi Training and Research Hospital

Diyarbakır, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019/215

Identifier Type: -

Identifier Source: org_study_id

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