NAFLD Study: US vs Liver Biopsy

• Sponsor: University of Roma La Sapienza (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04101162
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease	Diagnostic Test: shear waves elastography; liver biopsy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 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
• Actual Study Start Date: Sep 15, 2019
• Anticipated Primary Completion Date: Oct 15, 2020
• Anticipated Study Completion Date: Dec 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: liver biopsy	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)
Other: ATI	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)

Outcome Measures

Primary Outcome Measures

1. diagnostic accurancy of ATI in obese patients [6 months]

   a new ultrasound software compared with liver biopsy in obese patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Patients who are candidates for bariatric surgery between the ages of 18 and 65,

• BMI> 40 kg / m2, in the absence of any other comorbidity

• BMI> 35 kg / m2, in the presence of comorbidities among those classically considered to be associated with obesity

• ICM> 30 kg / m2, in the presence of T2DM not in glycometabolic compensation

1. Patients who are candidates for laparoscopic cholecystectomy for symptomatic calculi with BMI> 30

Exclusion Criteria:

• Age ≤ 18 or ≥ 65

• Any concurrent surgical procedure except cholecystectomy and hiatal hernia repair

• Conversion into laparotomy surgery

• Post-operative complications requiring new surgical treatment

• Patient not compliant in the follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICOT Latina	Latina	LT	Italy	04100

Sponsors and Collaborators

• University of Roma La Sapienza

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 8, 2019

More Information

Publications

None provided.

• Responsible Party: Gianfranco Silecchia, Professor, University of Roma La Sapienza
• ClinicalTrials.gov Identifier: NCT04101162
• Other Study ID Numbers: 0109926/2018
• First Posted: Sep 24, 2019
• Last Update Posted: Apr 1, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Apr 1, 2020