Study on diagnosis of NAFLD liver fibrosis using C-SWE

JRCT ID: jRCTs022240009

Registered date:10/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: NAFLD
• Date of first enrollment: 03/06/2024
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Abdominal ultrasonography with small shaker, C-SWE measurement, Extraction using software for shear wave imaging by C-SWE method, Liver biopsy

Outcome(s)

• Primary Outcome: 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 Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kuroda Hidekatsu