Study on diagnosis of NAFLD liver fibrosis using C-SWE

Study on the usefulness of continuous shear wave elastography in the diagnosis of liver fibrosis in the patients with NAFLD - Study on the usefulness of continuous shear wave elastography in the diagnosis of liver fibrosis in the patients with NAFLD

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs022240009

Enrollment

100

Registered

2024-06-10

Start date

2024-06-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD NAFLD, liver fibrosis

Interventions

Abdominal ultrasonography with small shaker, C-SWE measurement, Extraction using software for shear wave imaging by C-SWE method, Liver biopsy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients 20 years of age or older with NAFLD for whom a liver biopsy is scheduled and whose consent is obtained in writing after explanation using the consent document.

Exclusion criteria

Exclusion criteria: Patients who fall under any of the following 1) to 11). 1) Patients who consume more than 20 g of alcohol per day. 2) Patients with chronic hepatitis C, cirrhosis, or liver diseases other than NAFLD 3) Pregnant women, patients who may be pregnant, or patients who are breast-feeding. 4) Patients for whom a liver biopsy has not been performed 5) Patients with heart failure 6) Patients on dialysis therapy for renal failure 7) Patients with respiratory failure and on a ventilator 8) Patients with any of the following laboratory findings a) to e) at the time of enrollment a) ALT > 5 times the upper institutional limit b) Total bilirubin > 3.0 mg/dL c) PT-INR greater than 1.7 (except for patients taking warfarin) d) Albumin less than 2.0 g/dL e) Platelet count less than 50,000/mm3 9) Liver biopsy Patients who have been informed about the handling and research use of tissue obtained from liver biopsy at the time of the examination, but have not given their consent. 10) Patients who are restrained by legal procedures and cannot participate in this study of their own free will. 11) Other patients deemed inappropriate by the investigator.

Design outcomes

Primary

Measure	Time frame
Liver elasticity values obtained by C-SWE are compared with the degree of liver fibrosis progression by liver biopsy to evaluate the diagnostic accuracy of C-SWE.	—

Secondary

Measure	Time frame
Correlation coefficients will be calculated for conventional SWE, C-SWE, and liver histology results, and estimates of sensitivity, specificity, positive predictive value, and negative predictive value and their 95% confidence intervals will be calculated by ROC analysis. Furthermore, the diagnostic performance of C-SWE and serum fibrosis markers for liver fibrosis will be compared using the above method.	—

Measure

Time frame

Correlation coefficients will be calculated for conventional SWE, C-SWE, and liver histology results, and estimates of sensitivity, specificity, positive predictive value, and negative predictive value and their 95% confidence intervals will be calculated by ROC analysis. Furthermore, the diagnostic performance of C-SWE and serum fibrosis markers for liver fibrosis will be compared using the above method.

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Contacts

Public ContactTamami Abe

Iwate Medical University Hospital

mokosantokosan@yahoo.co.jp+81-19-613-7111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026