To evaluate our proposed SMS protocol in high-risk patients and compare it to a bi-annual US screening.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
lifetime costs, QALY and ICER
Background summary
Hepatocellular Carcinoma (HCC) comprises 75-85% of all liver cancer cases. The
current guidelines recommend bi-annual surveillance using ultrasound (US) for
high-risk patients.
US is widely available, however, US has a low sensitivity for detection of
early stage (small) HCC lesions. It is therefore of importance that new
surveillance modalities are developed. In this study, a Short MRI Surveillance
(SMS) protocol will be evaluated and will be compared to US.
Study objective
To evaluate our proposed SMS protocol in high-risk patients and compare it to a
bi-annual US screening.
Study design
This study is a prospective, multicentre, patient cohort study. Patients will
be recruited from six participating medical centers in The Netherlands,
including a total of 470 patients.
Study burden and risks
We have estimated an average of 2.5 paired (US and SMS) screenings for
patients, taking into account the dynamic study cohort during three years. The
US and SMS will be scheduled on the same day to limit inconvenience for
patients. In case of suspicious lesions on US and/or SMS patients will be
invited for a clinical applied full liver diagnostic MRI (Full MRI) within 2
weeks.
Before the end of the study period an online questionnaire will be conducted
for included patients with their permission. This questionnaire will be
performed, in cooperation with the NLV, to evaluate patient experience and
confidence with the SMS protocol.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
1. Patients aged <= 18 years at time of enrolment
2. Patients who decline to sign the written informed consent form
3. Patients with general contra-indications for undergoing MRI examination
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82538.078.23 |