A Study of the Usefulness of Two Ultrasound Elastographies in NAFLD

JRCT ID: jRCTs032200447

Registered date:27/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Nonalcoholic fatty liver disease
• Date of first enrollment: 10/03/2023
• Target sample size: 52
• Study type: Interventional
• Intervention(s): Using the results of liver fibrosis by liver biopsy as the gold standard, we will evaluate the superiority of specificity (the probability of judging a patient with F2 or lower as negative) for the diagnosis of advanced fibrosis (F3 or higher) by using two ultrasound elastography procedures. The main objective of this study is to evaluate the superiority of the specificity of two ultrasound elastography for the diagnosis of advanced fibrosis (non-F2) by predicting that only high/high biopsy is required for advanced fibrosis among low/low, low/high, high/low, and high/high. The diagnostic ability of advanced fibrosis) will be compared with the specificity of a single ultrasound elastography session. Secondary endpoints include sensitivity, positive predictive value, and negative predictive value.

Outcome(s)

• Primary Outcome: Specificity for diagnosis of advanced fibrosis by ultrasonic elastography performed once and twice

Secondary Outcome

Comparison of sensitivity in the diagnosis of advanced fibrosis compared to single ultrasound elastography
Positive predictive value for the diagnosis of advanced fibrosis compared to a single ultrasound elastography
Negative predictive value for the diagnosis of advanced fibrosis compared to a single ultrasound elastography

Key inclusion & exclusion criteria

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

Include criteria

1) Patients clinically diagnosed with non-alcoholic fatty liver disease and scheduled for liver biopsy
2) Patients who are at least 20 years old at the time of obtaining the consent form, regardless of gender
3) With or without hepatocellular carcinoma complications at the time of enrollment
4) Patients with a PS (ECOG performance status) of 2 or less and able to attend the outpatient clinic after 3 week of liver biopsy
5) Patients who have obtained written consent from the patient to participate in the study, who have complied with the requirements during their participation in the study, who have been examined as specified in the study protocol, and who are able to report their symptoms, etc.
6) Have participated in another clinical trial (including a clinical trial) prior to enrollment or are currently participating in another clinical trial, but would have no problem adding this study to the clinical trial in which they are participating.

Exclude criteria

(1) Patients with liver disease other than nonalcoholic fatty liver disease
2) Patients with malignant diseases other than hepatocellular carcinoma (however, patients who have undergone radical surgery or completed administration of anticancer drugs can be enrolled, but patients under observation and evaluation for malignancy are excluded)
3) Serious complications (liver disease: Child-Pugh classification C or higher, kidney disease: CKD stage 4 or higher, cardiac disease: NYHA classification III or higher)
4) Patients with serious mental illness
(5) patients who have been abusing alcohol and drugs
(6) Patients who are pregnant, lactating, may be pregnant, or wish to become pregnant
(7) Patients for whom a liver biopsy is contraindicated (bleeding tendency, ascites)
(8) Other patients who are deemed by the principal investigator (or sub-doctor) to be unsuitable as subjects

Related Information

• Primary Sponsor: Nogami Asako
• Source(s) of Monetary Support: Integral Corporation