Hepatic metastases of colorectal cancer (CRC) are partially necrotic tumors mainly vascularized by the hepatic artery. When resectable, these metastases must be removed with a safety margin of 1 mm. Resection margins greater than 1 cm are associated with better disease-free survival and no local recurrence. Thermoablation systems allow for ablation zones of approximately 4.5-5 cm in diameter. For tumors \<3 cm, subject to perfect targeting, it is possible to obtain ablation margins of 1 cm, which would greatly reduce the local recurrence rate. Accurate assessment of these tumor boundaries and characterization of these margins are paramount to ensure complete ablation. Thermoablation for these small liver metastases (\<3cm) has shown equivalent efficacy to surgery in terms of recurrence and survival with fewer complications. Thermoablation treatment is indicated for patients with stable disease undergoing chemotherapy. This leads to liver remodeling and metastases become difficult to see on ultrasound and CT scans. The study authors hypothesize that the porto-scanner guidance technique with Angio-CT for thermoablation treatment of CRC liver metastases will allow a better exploration of these metastases by allowing a better identification of the margins and thus ensure a more accurate and complete treatment for patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
7
Guidance with small volume breathing and high frequency. The contrast product will be venously injected in the elbow.
Real time guidance, small volume and high frequency respiration. Contrast medium will be directly injected into the superior mesenteric artery (SMA) after puncture of the femoral artery at the inguinal fold and catheterization of the SMA.
CHU de Montpellier
Montpellier, France
CHU de Nîmes
Nîmes, France
Efficacy of conventional CT versus porto-scanner for thermoablation of colorectal cancer liver metastases between groups
Percentage, where complete response is defined as complete ablation of the treated lesions (complete disappearance of enhancement and hypermetabolism) with no new lesions appearing, determined on imaging.
Time frame: 3 months
Difference in response rate per lesion between the groups
Percentage
Time frame: 3 months
Difference in distant recurrences between the groups
Time frame: 12 Months
Difference in local recurrences between the groups
Yes/no presence of recurrence
Time frame: 12 Months
Recurrence free survival between the groups
Days
Time frame: 12 months
Local recurrence-free survival between the groups
Days
Time frame: 12 months
Distant recurrence-free survival between the groups
Days
Time frame: 12 months
Difference in time until recurrence between the groups
Days
Time frame: 12 months
Size of the lesions
mm
Time frame: 3 months
Diameter of the tumor in axial
mm
Time frame: 3 months
Location of the lesions
Dome/left liver/sub capsular/contact with a large vessel (\> 5mm)
Time frame: 3 months
Size of the ablation area
mm
Time frame: 3 months
Feasibility of porto-scanner
Presence of metastatic lesions by scanner yes/no
Time frame: End of procedure (Day 0)
Complications arising during intervention
Complications related to the approach (vascular complications), related to the percutaneous procedure (hematoma, active bleeding) or related to the treatment; Clavien-Dindo classification
Time frame: End of procedure (Day 0) until 3 months
Reason for for failure of technique requiring switch to different guidance technique
Vascular problem (failure of catheterization) or problem of elevation (no optimal elevation of the liver allowing guidance)
Time frame: End of procedure (Day 0)
Cost estimates for both guidance techniques during intervention
Cost differential of the two guidance techniques for thermoablation of colorectal cancer liver metastases from the point of view of the healthcare facility
Time frame: End of procedure (Day 0)
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