Hepatitis, Teleradiology
Conditions
Brief summary
Comparison of abdominal US exam in patients with viral hepatitis between ultraportable US with teleradiology capacities (TUP) versus conventional ultrasound (CUS)
Detailed description
Primary Objective The investigation seeks primarily to determine the performance of abdominal US examinations realized with TUP and CUS based on defined imaging criteria Secondary Objectives Evaluate satisfaction and comfort and reproducibility of use of the ultraportable US
Interventions
DEVICETUP ultraportable US with teleradiology capacities
Comparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS).
DEVICECUS conventional ultrasound
Comparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS).
Sponsors
Naik Vietti Violi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed Consent signed by the subject * All adult patients with viral hepatitis for which an ultrasound is planned
Exclusion criteria
* Known or suspected non-compliance * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * Previous enrollment into the current study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of TUP versus CUS for abdominal imaging in patients with viral hepatitis according to US LI-RADS categories ) for liver lesions | At the end of intervention | LI RADS categories No observation OR Only definitely benign observation(s) Observation(s) \< 10 mm in diameter, not definitely benign Observation(s) ≥ 10 mm in diameter, not definitely benign OR New thrombus in vein |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| portal flow velocity | At the end of intervention | cm/s |
| biliary tract / gallbladder abnormalities | At the end of intervention | Yes/No |
| lymph nodes presence | At the end of intervention | Yes/No |
| free fluid | At the end of intervention | Yes/No |
| examination time | At the end of intervention | minutes |
| liver surface nodularity | At the end of intervention | Yes/No |
| caudate lobe dimensions | At the end of intervention | cm |
| liver visualization scores | At the end of intervention | no or minimal limitations; moderate limitations; severe limitations |
| audio quality | At the end of intervention | Adequate/Non Adequate |
| video quality | At the end of intervention | Adequate/Non Adequate |
| patient's satisfaction | At the end of intervention | Yes/No |
| agreement rates between reports | At the end of intervention | Category 1: complete agreement/matching with teleradiologists reports; Category 2: minor discrepancy that would not impact patient management which included hedging terminology and ambiguous differences, for example fatty versus moderate fatty liver; Category 3: major discrepancy that would likely have an impact/change on patient management but would not lead to an adverse outcome for the patient; Category 4: major discrepancy that would impact patient management and lead to adverse outcomes for the patient. |
| focal lesions | At the end of intervention | Yes/No |
Countries
Switzerland
Contacts
Primary ContactNaïk Vietti Violi, MD
Backup ContactGiuseppe Gullo, MSc
Outcome results
None listed