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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short MRI surveillance (SMS) protocol | Radiation | 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 | ||
| Bi-annual ultrasonography screening | Radiation | Bi-annual ultrasonography for screening of HCC in high-risk patients |
| Measure | Description | Time Frame |
|---|---|---|
| Increased sensitivity for HCC detection | Detection of HCC using the SMS protocol will be compared to US surveillance | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness analysis of SMS protocol | 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patients acceptance of the SMS protocol (through a questionnaire) | 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. | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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Patients with high-risk (cirrhosis and/or hepatitis) of developing HCC conform Dutch guidelines for HCC surveillance (https://www.oncoline.nl/hepatocellulair-carcinoom)
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. de Man | Erasmus Medical Center | Principal Investigator |
| Dr. Takkenberg | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Prof. Dr. Uyl-de Groot | Erasmus School of Health Policy & Management Rotterdam | Principal Investigator |
| Prof. Dr. IJzermans | Erasmus Medical Center | Principal Investigator |
| Dr. Bos | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | North Holland | 1105AZ | Netherlands | ||
| Medisch Spectrum Twente |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D005355 | Fibrosis |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D013097 | Spermine Synthase |
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D019883 | Alkyl and Aryl Transferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| Enschede |
| Overijssel |
| 7512KZ |
| Netherlands |
| Albert Schweitzer Ziekenhuis | Dordrecht | South Holland | 3318AT | Netherlands |
| Erasmus Medical Center | Rotterdam | South Holland | 3015GD | Netherlands |
| St. Franciscus Gasthuis & Vlietland | Rotterdam | South Holland | 3045PM | Netherlands |
| Maasstad Ziekenhuis | Rotterdam | South Holland | 3079DZ | Netherlands |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |