Comparison of the size and shape of the ablation zone of liver tumors with the simulation results of the CllnicIMPPACT software environment
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of the size and shape of the real ablation zone of liver tumors with
the simulation results of the ClinicIMPPACT software environment.
Secondary outcome
Evaluation of the workflow steps of the ClinicIMPPACT procedure.
Patient outcome (complications, tumor recurrence, survival)
Background summary
Patients with colorectal liver metastases are only suited for curative surgical
intervention in 10-25% of cases. This is due to several criteria for
resectability, such as, the size of the tumors, reserve liver parenchya,
comorbidity and extent of livercirrosis.
In order to increase the number of patients, eligible for curative treatment,
additional minimal invasive treatments have been developed, of which
radiofrequency ablation (RFA) is the most researched and used. This treatment
induced coagulation of the targeted lesion, using radiofrequency, and is
currently commonly used in the world.
However, the problem with this procedure is the lack and inability of real-time
monitoring during ablation. This can cause either under-treatment or
over-treatment of the lesion.
This research aims to evaluate a simulation software, which is capable to
estimate the expected ablation region. This can, in the future, be used to
optimize the treatment.
Study objective
Comparison of the size and shape of the ablation zone of liver tumors with the
simulation results of the CllnicIMPPACT software environment
Study design
15 patients will prospectively be included in this study. Patients will receive
an additional perfusion CT scan combined with their standard 1 week before
treatment planning CT scan. Following this CT, patients will receive ablation
of their tumors using RFA and will receive standard care follow-up.
Study burden and risks
Patients undergo only one form of burden/ risk during this research:
During the standard preoperative planning CT, instead of a 4 phase CT liver,
patients will receive an combined scan with perfusion and 4 phase.
The added amount of radiation is comparable to the normal preoperative planning
CT.
Geert Grootteplein 10
Nijmegen 6500 HB
NL
Geert Grootteplein 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria:
• patients admitted for radiofrequency ablation (RFA) of a liver tumor (maximum tumor diameter of 3 cm, max. 3 lesions)
• age >= 18 years
• written informed consent
Exclusion criteria
Exclusion criteria
• known anaphylactic reaction against iodine / contrast agent
• malfunction of the kidney (non treatable renal insufficiency; MDRD< 25)
• thyroid disease (non treatable hyperthyreosis)
• Splenectomy
• pregnant or nursing women
• concurrent participation in other interventional trials
Design
Recruitment
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 | NL54334.091.15 |