NCT04101162

NAFLD Study: US vs Liver Biopsy

Diagnostic Accuracy in a New Ultrasound Software Compared to Histology for Non Alcoholic Fatty Liver Disease (NAFLD) and Non Alcoholic Steato Hepatitis (NASH) in Morbidly Obese Individuals Undergoing Bariatic Surgery and/or Cholecystectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evaluate the diagnostic accuracy of the new ultrasound software vs hepatic histology, the current reference standard for the diagnosis of NAFLD and NASH in 20 obese patients (BMI\> 30) candidates for laparoscopic bariatric surgery and / or cholecystectomy

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	shear waves elastography; liver biopsy	Diagnostic accuracy in a new ultrasound software compared to histology for Non Alcoholic Fatty liver disease (NAFLD) and Non Alcoholic Steato Hepatitis (NASH)

Timeline

• Start date: 2019-09-15
• Primary completion: 2020-10-15
• Completion: 2020-12-15
• First posted: 2019-09-24
• Last updated: 2020-04-01

Locations

1 site across 1 country: Italy