Hepatocellular Carcinoma
Conditions
Keywords
Cirrhosis, Hepatitis, Hepatocellular carcinoma, MRI, Surveillance
Brief summary
The investigators will assess implementation of the proposed SMS protocol as a surveillance tool in patients at high risk of developing HCC in a prospective multicenter study.
Detailed description
Over the past 20 years, the prevalence of HCC has been growing extensively. HCC makes up for 75-85% of primary liver cancers and has a poor prognosis with a 5-year survival rate lower than 20%. The incidence of HCC is higher in patients diagnosed with hepatitis and/or cirrhosis. The current guidelines recommend a bi-annual US screening of this patient group. However, recent meta-analysis showed that the sensitivity of such US surveillance for detecting early stage HCC is merely 47%. In addition, early detection of small HCC lesions (with a diameter less than 2 cm) will provide a higher survival chance. It is therefore of major importance to develop a better surveillance tool. The use of MRI should be considered as a surveillance tool for this patient group. In comparison to US, MRI come with high cost, long duration of the scan, limited availability and a potential risk related to the use of contrast agents. The investigators have developed and validated a short MRI surveillance (SMS) protocol for HCC screening in high-risk patients. This protocol has been evaluated among a database of 215 patients. In this prospective, multicenter study, the investigators will evaluate the value of the SMS protocol in a high-risk patient group and they will assess the cost-effectiveness of the SMS protocol as a surveillance tool with respect to a bi-annual US screening.
Interventions
RADIATIONShort MRI surveillance (SMS) protocol
Bi-annual, non-contrast agents, MRI screening consisting of Diffusion Weighted Imaging (b-values of 50 and 800 s/mm2), T2-weighted imaging and T1-weighted in- and out-of-phase imaging
RADIATIONBi-annual ultrasonography screening
Bi-annual ultrasonography for screening of HCC in high-risk patients
Sponsors
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Male and female patients above 18 years of age * High-risk patients with cirrhosis and/or hepatitis
Exclusion criteria
* Patients below the age of 18 years * Patients who will not sign the informed consent form * Patients with general contra-indications for undergoing MRI examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increased sensitivity for HCC detection | 3 years | Detection of HCC using the SMS protocol will be compared to US surveillance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness analysis of SMS protocol | 2 years | A cost-effectiveness analysis will be performed for the SMS protocol by measuring all direct medical costs. Using a Markov Model, the final outcome will give us an incremental cost-effectiveness ratio. Although direct costs of MRI (SMS protocol) are higher than US, improved detection of early HCC with SMS may finally prove more cost-effective than US |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patients acceptance of the SMS protocol (through a questionnaire) | 3 years | Patients will be invited to circumvent their personal experiences, including confidence with both the SMS and US. The outcome may prove patients acceptance of SMS as the new standard for HCC surveillance. |
Countries
Netherlands
Outcome results
None listed