Quantitative US for Evaluation of Hepatic Steatosis in MAFLD With UDFF

NCT06097338 | Not Yet Recruiting

• 1 other identifier: QFS-UDFF2023
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ultrasound Derived Fat Fraction (UDFF) Evaluation of Metabolic Related Fatty Liver Disease (MAFLD) in obesity Patients Metabolic fatty liver disease (MAFLD), formerly known as Nonalcoholic Fatty Liver Disease (NAFLD), is the most common chronic liver disease in the world at present, with a incidence rate of about 30%. In the United States, NAFLD is the third leading cause of hepatocellular carcinoma, and early assessment and diagnosis of liver steatosis characteristics are crucial for timely treatment or intervention to reduce the risk of liver fibrosis and inhibit disease progression. Liver biopsy is considered as the "gold standard" for evaluating, grading, and determining inflammatory activity of liver steatosis and fibrosis. However, liver biopsy are invasive and pathological evaluation differences among observers, which makes it difficult to widely use and repeat, especially for dynamic evaluation of patients during the treatment process. Ultrasound Derviced Fat Fraction (UDFF) is a unique technology for non-invasive quantification of liver fat content, which is equipped on the Siemens ACUSON Sequoia ultrasound system. UDFF is calculated from two parameter values: attenuation coefficient (AC) and backscatter coefficient (BSC). SWE (shear wave elastography) is becoming widely used, and is recommended for the evaluation of liver fibrosis by some guidelines in patients with chronic liver diseases, such as viral hepatitis. These two technologies (UDFF+SWE) can be achieved on the same probe, and this detection technology is non-invasive, painless, simple, and reliable. Bariatric surgery (BS), also known as metabolic weight loss surgery, is currently recognized as the most significant and long-lasting method for treating obesity. It can significantly improve obesity related comorbidities, as well as long-term improvement in postoperative quality of life and mental state. This study will aim on analysis of the liver ultrasound characteristics of patients who plan to undergo bariatric surgery. By using UDFF and elastic shear wave technology (UDFF+SWE), a new non-invasive ultrasound evaluation method for MAFLD grading diagnosis of simple fatty liver, fatty hepatitis, liver fibrosis, and related cirrhosis will be proposed, and the incidence and risk factors of MAFLD in overweight and obese patients will be explored, The reversal effect of weight loss therapy on MAFLD in obese patients.

Conditions

Fatty Liver Disease, Nonalcoholic

Keywords

metabolism related fatty liver disease (MAFLD); Ultrasound Derived Fat Fraction (UDFF); bariatric surgery; Shear wave elastography

Outcome Measures

Primary Outcomes (1)

• The combined detection of UDFF and SWE based on ultrasound images

  UDFF technology will be used to detect liver fat content in patients who plan to undergo weight loss surgery, while SWE will be used to monitor liver hardness. Pathological diagnosis will be used as the gold standard to determine the correlation between relevant feature quantities and fibrosis grade, inflammation grade grade, and lipid degeneration grade. Multiple regression equations will be established to form UDFF scores for different degrees of MAFLD and different grading diagnostic thresholds. Analyze its diagnostic effectiveness through internal and external verification methods.

  12 months

Study Arms (2)

MAFLD patients

MAFLD patients undergoing weight loss surgery

Procedure: bariatric surgery (BS)

healthy volunteers

healthy volunteers

Interventions

bariatric surgery (BS) PROCEDURE

bariatric surgery (BS) is a very attractive choice for severely obese patients. After bariatric surgery, long-term weight loss (15%-25%) and diabetes remission can occur \[16\], as well as long-term mortality, cardiovascular events and tumor occurrence \[17\]. Regardless of the surgical procedure used for weight loss surgery, studies have shown that weight loss surgery can significantly reduce the liver NAFLD activity score (from 5 to 1), and 33.8% of patients have reduced liver fibrosis \[18\]. The follow-up results for a longer period of time (10 years) also indicate that weight loss surgery significantly reduces the occurrence of major adverse outcomes related to liver cirrhosis, liver cancer, liver transplantation, and liver related deaths

MAFLD patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the hospitalized patients plan to undergo bariatric surgery in the First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital

You may qualify if:

• Chinese citizens aged 18 ≤ 85;
• Routine ultrasound reveals diffuse or non-uniform fatty liver disease in the liver;
• Conform to the MAFLD diagnostic criteria issued by the international guidelines: histological (liver biopsy), imaging or blood biomarker evidence based on liver fat accumulation (hepatocyte steatosis), and combine one of the following three conditions: overweight/obesity (BMI ≥ 23 kg/m2), type 2 diabetes, and metabolic dysfunction. The definition of metabolic dysfunction is the presence of at least two of the following metabolic risk factors: 1. waist circumference (for Asians) ≥ 90/80 cm (male/female);2. Arterial blood pressure ≥ 130/85 mmHg is being treated with antihypertensive drugs; 3. Hypertriglyceridemia (TG): fasting serum TG ≥ 150 mg/dl (≥ 1.70 mmol/L) or being treated with lipid-lowering drugs; 4. High density lipoprotein cholesterol (HDL-c) emia: fasting serum HDL-c\<40 mg/dl (\<1.0 mmol/L) for males,\<50 mg/dl (\<1.3 mmol/L) for females, or specific medication treatment;5. Pre diabetes (i.e. fasting blood glucose level 100-125 mg/dl \[5.6-6.9 mmol/L\], or blood glucose level 140-199 mg/dl \[7.8-11.0 mmol\] 2 hours after meal or HbA1c 5.7% -6.4% \[39-47 mmol/mol\]);6. Steady state model evaluation of insulin resistance score ≥ 2.5;7. Plasma C-reactive protein levels\>2 mg/L.
• Those who plan to undergo liver histopathological diagnosis or MRI-PDFF assessment of the degree of fatty liver within one week;
• No significant risk of bleeding (platelet ≥ 50x109/L, international standardized ratio of prothrombin time INR ≤ 1.5);
• The patient agrees to join this study and signs an informed consent form.

You may not qualify if:

• \. No histopathological diagnosis or MRI-PDFF was found;
• \. The interval between the ultrasound UDFF examination and the histopathological examination or MRI-PDFF examination is more than one week;
• \. Pregnancy;
• \. Incomplete medical history information.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Related Publications (17)

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MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Zhe Ma, MD，PHD

  Department of Ultrasound, Shandong Provincial Qianfoshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Fangqiong Luo, MD, PHD

CONTACT

+8615666668596; luo_fangqiong@hotmail.com

Meng Lan, MD

CONTACT

＋86053189268481

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share