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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00199-36 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| only one treatment group | Experimental | Patients presenting inoperable venous vascular malformations in soft tissues with indication of cryoablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles) | Device | Treatment consists of a percutaneous cryoablation performed under anesthesia and imaging control. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale. | 7 days after cryoablation | |
| To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale. | 1 month after cryoablation | |
| To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale. | 2 months after cryoablation | |
| To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale. | 6 months after cryoablation |
| Measure | Description | Time Frame |
|---|---|---|
| All adverse events using NCI-CTCAE | 7 days, 1 month ,2 months + 6 months after cryoablation | |
| Clinical response (decrease of pain and/or functional discomfort) | 6 months after cryoablation | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François Cornelis, MD | University Hospital Bordeaux, France | Principal Investigator |
| Adelaide Doussau, MD | University Hospital Bordeaux, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bordeaux, France | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22722720 | Background | Cornelis F, Neuville A, Labreze C, Kind M, Bui B, Midy D, Palussiere J, Grenier N. Percutaneous cryotherapy of vascular malformation: initial experience. Cardiovasc Intervent Radiol. 2013 Jun;36(3):853-6. doi: 10.1007/s00270-012-0434-9. Epub 2012 Jun 22. | |
| 23491212 | Background | Cornelis F, Havez M, Lippa N, Al-Ammari S, Verdier D, Carteret T, Amoretti N, Gangi A, Palussiere J, Hauger O, Grenier N. Radiologically guided percutaneous cryotherapy for soft tissue tumours: A promising treatment. Diagn Interv Imaging. 2013 Apr;94(4):364-70. doi: 10.1016/j.diii.2013.02.001. Epub 2013 Mar 11. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009339 | Needles |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Imaging response (RECIST 1.1) |
| 6 months after cryoablation |
| Quality of life using QLQ-C30 | 2 months & 6 months after cryoablation |
| Pain using visual analogue scale | 7 days, 1 month ,2 months & 6 months after cryoablation |
| 9298055 | Background | Barza M, Pavan PR, Doft BH, Wisniewski SR, Wilson LA, Han DP, Kelsey SF. Evaluation of microbiological diagnostic techniques in postoperative endophthalmitis in the Endophthalmitis Vitrectomy Study. Arch Ophthalmol. 1997 Sep;115(9):1142-50. doi: 10.1001/archopht.1997.01100160312008. |
| 28361195 | Result | Cornelis FH, Labreze C, Pinsolle V, Le Bras Y, Castermans C, Bader C, Thiebaut R, Midy D, Grenier N. Percutaneous Image-Guided Cryoablation as Second-Line Therapy of Soft-Tissue Venous Vascular Malformations of Extremities: A Prospective Study of Safety and 6-Month Efficacy. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1358-1366. doi: 10.1007/s00270-017-1636-y. Epub 2017 Mar 30. |