Hepatocellular Carcinoma
Conditions
Interventions
magnetic resonance scanners for the whole body
Signa Artist 1.5T, Versie Rev
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients age >= 18 years at time of enrolment 2. Patients diagnosed with chronic hepatitis B a. All patients diagnosed with chronic hepatitis B and liver cirrhosis b. The following patients diagnosed with chronic hepatitis B without liver cirrhosis i. East-Asian men >= 40 years of age ii. East-Asian women >= 50 years of age iii. Patients from sub-Saharan Africa >= 20 years of age iv. Patients with HCC family history 3. Patients diagnosed with non-hepatitis B cirrhosis a. Patients diagnosed with hepatitis C b. Patients diagnosed with alcoholic cirrhosis c. Patients diagnosed with hemochromatosis d. Patients diagnosed with primary biliary cirrhosis
Exclusion criteria
Exclusion criteria: 1. Patients aged
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study objective of this study is to compare the sensitivity of the SMS protocol with that of US surveillance for the detection of HCC. The reference standard to which both strategies will be compared is the full-liver MRI. Using standard methodology for diagnostic research we will calculate the sensitivity (2x2 contigency tables). Additionally, the specificity, positive predictive value (PPV) and negative predictive value (NPV) of the SMS protocol and US will be calculated. McNemar*s test will be used to test whether the potential difference in sensitivity between SMS and US is statistically significant. | — |
Secondary
| Measure | Time frame |
|---|---|
| The cost-effectiveness analysis will be performed from a healthcare perspective using costs per detected cancer as outcome. Hereto, we measure all direct medical costs which will be collected from hospital databases and literature using the year 2023 as price level within both diagnostic pathways. The cost-effectiveness analysis will be perfomed according to the Dutch guidelines and by using a Markov model. The final outcome will be an incremental cost-effectiveness ratio (ICER). This ratio expresses the difference in costs between SMS and US pathway per unit of health gain (detected cancer and quality adjusted life years (QALYs)). The uncertainty around the estimates will be addressed using deterministic and probabilistic sensitivity analyses. We need information on the QALYs and ICER gained by diagnosis of HCC with MRI versus US. It is safe to assume that the prognosis of HCC detected at an early stage with SMS is more favourable than the prognosis of HCC detected in a more advanced stage by US. Data from this trial, literature and expert opinion will be used to calculate the impact of earlier detection of smaller lesions on outcomes (i.e. progression free survival and overall survival). In combination with the fact that the early HCC require less extensive treatment, we expect that valuable QALYs and ICER might be gained by using SMS. We hypothesize that screening with biannual SMS is more cost-effective than screening with biannual US, with improved clinical outcomes at a reasonable cost. If the hypothesis is proven correct, then further research may show whether annual screening with SMS will suffice instead of semi-annual SMS, based on the rational that our retrospective study as described above was performed with data derived from patients with annual screening with full liver MRI. This may eventually prove that the direct costs of annual SMS roughly equals that of bi-annual US, but at an improved cost-effectiveness considering | — |
Countries
Netherlands
Contacts
Public ContactI Jole
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed