Clinical trial NCT01845935: Cryoablation of Venous Vascular Malformations
Official title: Cryoablation of Venous Vascular Malformations Located in Soft Tissues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Venous Vascular Malformation
Keywords: Cryoablation
Venous vascular malformation
MRI
safety
pain
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years,
* Initial radiological diagnosis of venous or glomovenous vascular malformation proved by Doppler ultrasound and MRI,
* Recurrence of symptoms after initial treatment,
* Symptomatic deformation :pain, tangible mass,functional discomfort
* Recurrence after treatment by surgery or sclerosis
* Cryotherapy considered technically feasible after discussion in multidisciplinary committee,
* Localization at distance from the skin and major neurovascular structures,
* Absence of contra-indication of anaesthesia,
* Signed informed consent,
* Coverage by French social security

Exclusion Criteria:

* Localization of the lesion does not allow the implementation of cryotherapy in adequate conditions: ablation zone too close to the major anatomic structures (nerve),
* TP \<50% TCA\> 1.5 x control, anticoagulation
* Platelets \<90000/mm3,
* Progressive infection
* Patient included in another clinical study,
* Unable to undergo medical tests for geographical, social or psychological,
* Adult under a legal guardianship or unable to consent,
* Pregnancy and breastfeeding.

Primary outcomes:
measure: To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale.
timeFrame: 7 days after cryoablation
measure: To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.
timeFrame: 1 month after cryoablation
measure: To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.
timeFrame: 2 months after cryoablation
measure: To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale.
timeFrame: 6 months after cryoablation
Secondary outcomes:
measure: All adverse events using NCI-CTCAE
timeFrame: 7 days, 1 month ,2 months + 6 months after cryoablation
measure: Clinical response (decrease of pain and/or functional discomfort)
timeFrame: 6 months after cryoablation
measure: Imaging response (RECIST 1.1)
timeFrame: 6 months after cryoablation
measure: Quality of life using QLQ-C30
timeFrame: 2 months & 6 months after cryoablation
measure: Pain using visual analogue scale
timeFrame: 7 days, 1 month ,2 months & 6 months after cryoablation
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital Bordeaux, France
Study officials:
affiliation: University Hospital Bordeaux, France
name: François Cornelis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bordeaux, France
name: Adelaide Doussau, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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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