Non-Alcoholic Fatty Liver DiseaseNAFLDNCT04101162
NAFLD Study: US vs Liver Biopsy
A study testing shear waves elastography; liver biopsy in people with Non-Alcoholic Fatty Liver Disease, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- shear waves elastography; liver biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2019to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ICOT Latina
Latina, LT, 04100
Gianfranco Silecchia, medicine, +3907736511, info@giomi.com
About this study
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
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
- Being tested
- shear waves elastography; liver biopsy
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shear waves elastography; liver biopsyDiagnostic test
Diagnostic accuracy in a new ultrasound software compared to histology for Non Alcoholic Fatty liver disease (NAFLD) and Non Alcoholic Steato Hepatitis (NASH)
| Study group | Role | What they receive |
|---|---|---|
| liver biopsy | Other | Not described Receives: Diagnostic Test: shear waves elastography; liver biopsy |
| ATI | Other | Not described Receives: Diagnostic Test: shear waves elastography; liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accurancy of ATI in obese patients
a new ultrasound software compared with liver biopsy in obese patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start15 Sep 2019
- Primary completion15 Oct 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianfranco Silecchia, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101162
- Sponsor's protocol ID
- 0109926/2018
- Acronym
- NAFLD
- Status last verified
- Mar 2020
- First submitted
- 5 Sep 2019
- Last updated
- 1 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04101162
- Acronym / sponsor ID
- NAFLD / 0109926/2018
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liver biopsy | Other | Diagnostic Test: shear waves elastography; liver biopsy |
| ATI | Other | Diagnostic Test: shear waves elastography; liver biopsy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are candidates for bariatric surgery between the ages of 18 and 65,
- Patients who are candidates for laparoscopic cholecystectomy for symptomatic calculi with BMI> 30
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shear waves elastography; liver biopsyDiagnostic accuracy in a new ultrasound software compared to histology for Non Alcoholic Fatty liver disease (NAFLD) and Non Alcoholic Steato Hepatitis (NASH) | Diagnostic test | ATI, liver biopsy |
Primary outcome
diagnostic accurancy of ATI in obese patients
Time frame: 6 months
a new ultrasound software compared with liver biopsy in obese patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shear waves elastography; liver biopsy in people with Non-Alcoholic Fatty Liver Disease, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANNA GUIDA, medicine (+393288699401, anna.guida88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accurancy of ATI in obese patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.