NAFLD Study: US vs Liver Biopsy | NCT04101162

Studies
NAFLD Study: US vs Liver Biopsy

NCT04101162

Sponsor

University of Roma La Sapienza

Status

Unknown status

Last Update Posted

Apr 1, 2020Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

shear waves elastography; liver biopsy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2019Actual

Primary Completion Date

Oct 15, 2020Estimated

Completion Date

Dec 15, 2020Estimated

First Submitted Date

Sep 5, 2019

First Submission Date that Met QC Criteria

Sep 20, 2019

First Posted Date

Sep 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2020

Last Update Posted Date

Apr 1, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
liver biopsy	Other		Diagnostic Test: shear waves elastography; liver biopsy
ATI	Other		Diagnostic Test: shear waves elastography; liver biopsy

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnostic accurancy of ATI in obese patients	a new ultrasound software compared with liver biopsy in obese patients.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ANNA GUIDA, medicine	Contact	+393288699401		anna.guida88@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ICOT Latina	Recruiting	Latina	LT	04100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 8, 2019	Sep 19, 2019	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

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Browse Branches

Not provided