Hepatocellular Carcinoma, Hepatocellular Carcinoma by BCLC Stage
Conditions
Keywords
Transarterial Chemoembolization, RECIST, mRECIST, Volumetric analysis
Brief summary
The application of transarterial chemoembolisation (TACE) with drug-eluting beads in patients with hepatocellular carcinoma and its response to the treatment will be observed. The registry has the following objectives: To assess the response to the treatment by standard methods and volumetric analysis as well as trying to determine any predictive response factors To determinate interobserver variability of the methods.
Detailed description
The patients with hepatocellular carcinoma in stage suitable for treatment by transarterial chemoembolization (TACE) with drug-eluting beads are included in the study. The investigators assess the response to the treatment by standard methods (RECIST, mRECIST) as well as by volumetric analysis. The size of tumor is evaluated on CT/MRI by two investigators prior to first TACE and then on all the check-ups (routinely every three months) until 31 December, 2019 or the patients' death.
Interventions
PROCEDURETransarterial Chemoembolization
A contrast agent (Xenetix350, Guerbet, France) was applied under local anaesthesia via the common femoral artery using a 5F sheath. Selective catheterization of the coeliac trunk and other arteries supplying the liver was then performed under fluoroscopic control. A pathological vascularization pattern was identified and chemoembolization material consisting of DC beads (BTG International Ltd) was injected by the treating angiographist using micro instrumentation. Follow-up CT or MRI was performed after 1-3 TACE sessions according to the extent of the lesion, 3 weeks following the last procedure. Patients with completed treatments were scheduled for an imaging follow-up every 3 months, allowing evaluation of the effect of treatment. In case of a positive response to the treatment another session of TACE was indicated. Chemoembolization sessions were performed as inpatient procedures with the mean hospitalization time of 4 days.
Sponsors
Masaryk Memorial Cancer Institute
Masaryk University
Brno University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of HCC by a radiologist according to the European Association for the Study of the Liver (EASL) criteria or confirmed histologically * at least one TACE undergone at the University Hospital Brno * initial/ closing CT (Brillance 64, Philips, Netherlands; contrast enhancement 125 mL Iomeron 400, Bracco, Germany) or MRI study (Achieva, Philips, Netherlands, SENSE XL Torso coil 16 1.5T; contrast enhancement 15 mL Primovist, Bayer, Germany) * follow-up on or before December 31, 2019.
Exclusion criteria
* when the inclusion criteria are not met.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive factors for overall survival and progression-free survival | 4 years 11 months | RECIST, mRECIST, volumetric analysis |
| Interobserver variability of the methods used for assessing tumor response to the treatment | 4 years 11 months | RECIST, mRECIST, volumetric analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response to the treatment, as assessed by RECIST (v.1.1) | 4 years 11 months | Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis |
| Time from observation until death due to any cause (or censoring) | 4 years 11 months | Overall survival |
| Response to the treatment, as assessed by volumetric analysis | 4 years 11 months | Objective Tumour Response will be assessed by the investigators on CT/MRI image |
| Response to the treatment, as assessed by mRECIST | 4 years 11 months | Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis |
| Time from observation until disease progression or death | 4 years 11 months | Progression-free survival |
Outcome results
None listed