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Comparison of abdominal US exam in patients with viral hepatitis between ultraportable US with teleradiology capacities (TUP) versus conventional ultrasound (CUS)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with viral hepatitis | Every outpatient referred to the radiology department by a prescriber for abdominal US in the context of viral hepatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TUP ultraportable US with teleradiology capacities | Device | Comparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS). |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of TUP versus CUS for abdominal imaging in patients with viral hepatitis according to US LI-RADS categories ) for liver lesions | 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 | At the end of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| liver visualization scores | no or minimal limitations; moderate limitations; severe limitations | At the end of intervention |
| liver surface nodularity | Yes/No |
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Inclusion Criteria:
Exclusion Criteria:
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Every outpatient referred to the radiology department by a prescriber for abdominal US in the context of viral hepatitis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naïk Vietti Violi, MD | Contact | +41795560240 | naik.vietti-violi@chuv.ch | |
| Giuseppe Gullo, MSc | Contact | +41213144444 | giuseppe.gullo@chuv.ch |
| Name | Affiliation | Role |
|---|---|---|
| Naïk Vietti Violi, MD | CHUV-UNIL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lausanne University Hospital | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| CUS conventional ultrasound | Device | Comparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS). |
|
| At the end of intervention |
| focal lesions | Yes/No | At the end of intervention |
| caudate lobe dimensions | cm | At the end of intervention |
| portal flow velocity | cm/s | At the end of intervention |
| biliary tract / gallbladder abnormalities | Yes/No | At the end of intervention |
| lymph nodes presence | Yes/No | At the end of intervention |
| free fluid | Yes/No | At the end of intervention |
| examination time | minutes | At the end of intervention |
| audio quality | Adequate/Non Adequate | At the end of intervention |
| video quality | Adequate/Non Adequate | At the end of intervention |
| patient's satisfaction | Yes/No | At the end of intervention |
| agreement rates between reports | 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. | At the end of intervention |