To now, two alternatives for the management of venous vascular malformations are recognized, appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is effective on symptoms in 80% of cases and excision removes the malformation completely or partially, but it is aggressive and recurrences are common.
In order to propose an additional alternative option, cryoablation has been recently tested with promising results. Therefore, the purpose of this study is to evaluate the safety and efficacy of cryotherapy on venous vascular malformations. Fourteen patients will be included after discussion in multidisciplinary meeting. Patients will be follow until 6 months to evaluate the safety and the 6 months efficacy on symptoms. A MRI will be perform at 6 months to evaluate the size of ablated zone following RECIST criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Treatment consists of a percutaneous cryoablation performed under anesthesia and imaging control.
University Hospital Bordeaux, France
Bordeaux, France
To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale.
Time frame: 7 days after cryoablation
To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.
Time frame: 1 month after cryoablation
To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.
Time frame: 2 months after cryoablation
To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale.
Time frame: 6 months after cryoablation
All adverse events using NCI-CTCAE
Time frame: 7 days, 1 month ,2 months + 6 months after cryoablation
Clinical response (decrease of pain and/or functional discomfort)
Time frame: 6 months after cryoablation
Imaging response (RECIST 1.1)
Time frame: 6 months after cryoablation
Quality of life using QLQ-C30
Time frame: 2 months & 6 months after cryoablation
Pain using visual analogue scale
Time frame: 7 days, 1 month ,2 months & 6 months after cryoablation
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