Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy

Study Overview
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Brief Summary
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This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT (intervention group) or reconstruction with implants (control group). AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness.

Official Title
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the Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: autologous fat transfer
* Procedure: breast implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female gender Age of 18 years and older History or in candidate for a mastectomy procedure in the near future Patients' choice to undergo a breast reconstruction Wanting to participate in this study Patient is able to wear the BRAVA device Exclusion Criteria: Active smoker or a history of smoking 4 weeks prior to surgery Current substance abuse History of lidocaine allergy History of silicone allergy 4 weeks or less after chemotherapy History of radiation therapy in the breast region Oncological treatment includes radiotherapy after mastectomy Kidney disease Steroid dependent asthma (daily or weekly) or other diseases Immune-suppressed or compromised disease Uncontrolled diabetes BMI>30 Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction The treating plastic surgeon has strong doubts on the patient's treatment compliance Claustrophobia for an MRI-scan

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous fat transfer reconstruction<br>Breast reconstruction achieved by serial autologous fat transfer (AFT) procedures, accompanied by external tissue expansion of the breast. | Procedure: autologous fat transfer<br>* Each procedure consists of the transfer of syringe-aspirated fat (form the abdomen, thighs, flanks) to the breast by injection in the subcutaneous planes. Typically three separate procedures are needed for a complete breast reconstruction: First session comprises of sub- and intrapectoral fat transfer during the primary mastectomy surgery, providing volume to the deep tissue planes. Second session is preceeded by wearing an external pre-expansion device to prepare the recipient site for grafting. It aims to give the breast its shape and initial volume. Third session is also preceded by external pre-expansion and aims to provide extra volume of the breast to achieve symmetry with the healthy breast.<br>* Other names: autologous fat injection;|
| Active Comparator: Reconstruction with breast implants<br>Control group will receive implant-based reconstruction, in some cases preceded by the implantation of a tissue expander. | Procedure: breast implant<br>* Implant-based reconstruction typically will occur as follows: During the primary mastectomy surgery, a tissue expander will be implanted subpectorally. The tissue expander will be gradually filled with sterile saline during outpatient clinic visits. When the desired volume is achieved, a second operation will be planned, to exchange the tissue expanded with the definite breast implant. (Note: in patients who are receiving encapsulectomy and implant exchange, the first 2 steps are skipped.)<br>* Other names: breast prosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast-related Quality of life (BREAST_Q) | Measured by the BREAST-Q questionnaire (quality of life subdivision) preoperatively and 1 year postoperatively | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic result | The overall aesthetic result will be measured using 3D-photographs which will be assessed by a panel of independent plastisch surgeons, ex-breast cancer patients and healthy volunteers. In addition, the volume, shape and symmetry will be assessed by the patient using the BREAST-Q questionnaire (satisfaction with breasts subdivisions) at 1 year postoperatively. | 1 year | 
| Complications | Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events. | 1 year | 
| Oncological safety | Oncological follow-up will comply to the guidelines for breast cancer and will take place by a yearly consult with the oncological surgeon (including physical examination and mammography/ultrasound/MRI) for 5 years postoperatively. All (loco)regional and distant recurrences will be recorded and compared between both grops. | 5 years | 
| Cost-effectiveness | Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment. It will be calculated according to the guidelines of the Instuction manual cost-effectiveness analysis (Handleiding kostenonderzoek) of the Dutch Health Institute (Zorginstituut Nederland). | 1 year | 
| Sensibility | Measurement of skin sensitivity with Semmes Weinstein Monofilaments, 12 months after final reconstruction surgery. | 1 year | 
| Donor site satisfaction | Measurement of quality of life and satisfaction at AFT donor sites, as measured by the BODY-Q questionnaire and additional questions concerning liposuction sites. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fat grafting, fat injection, lipoaspirate, fat transfer, lipofilling, liposculpturing, lipoinjection, lipotransfer, breast reconstruction, external pre-expansion, BRAVA, EVE