Clinical trial NCT04273464: Breast Reconstruction With Autologous Tissue: Microsurgery or Fat Grafting?
Official title: Secondary Breast Reconstruction in Irradiated Patients - Prospective Trial Comparing DIEP to Brava Expansion + Fat Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Mammaplasty
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
First posted: 2020-02-18
Enrollment: 57
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective comparative study of two parallell cohorts (BRAVA and DIEP reconstruction methods).
Primary purpose: TREATMENT

Brief summary: Methods for breast reconstruction after mastectomy vary from rather simple techniques using expanders and implants, local flaps alone or in combination with implants, to more complex methods using autologous tissue.Transverse rectus abdominis muscle (TRAM) flap has since 1983 become golden standard in autologous breast reconstruction. The deep inferior epigastric perforator (DIEP)-flap, the very last improvement of TRAM flap, has been used in breast reconstruction after mastectomy and radiation therapy as the method of choice at the Department for Plastic Surgery at Hospital of Telemark since 2000.Transplantation of fat tissue by lipoinjections is an alternative method for partial breast reconstruction. In recent years, fat transplantation techniques have gained interest even for patients after mastectomy, as donor site morbidity and operative trauma seem to be less than when free flaps are used. Best results are obtained if the skin around mastectomy scar is pretreated with external expansion. The results of breast reconstruction with fat transplantation are promising, but have not been compared to microsurgical reconstruction of the breast in a scientific manner. The present project is designed to address clinical questions regarding efficiency and patient satisfaction of the two methods.

Detailed description: When used for breast reconstruction on irradiated patients, breast implants can result in 50% or higher rate of complications included capsular contracture and implant rupture. For this reasons secondary breast reconstruction in irradiated patients is preferably done with autologous tissue.Reconstruction methods employing microvascular transfer of autologous tissue are time consuming having a long learning curve for surgeons. The present project aims to evaluate fat transplantation in combination with external tissue expansion (Brava method) as an alternative to microsurgical complexe methods.

Hypothesis: Early complication/ drop out occur more frequently in fat transplantated patients.

Methods: External tissue expanders (Brava, Brava, LLC 14221 SW 142nd St, Miami, FL 33186) will be used 3 weeks prior to reconstruction in order to enhance the volume and survival of fat cells. The investigators expect that each patient in the fat transplantation group will need 4-6 transplantation sessions of about 1.5 to 2 hours each to achieve satisfactory volume and shape of the breast. The investigators expect 1-2 operative sessions of respectively 5-7 and 2-3 hours duration in the DIEP group. The risk of reoperation (second operation during the first postoperative week) in the DIEP group is 5-10 %.

Patients in the fat transplantation group experiencing poor compliance or early complications as well as patients with unsatisfactory results will be offered alternative methods of reconstruction such as superior or inferior gluteal perforator flap (SGAP or IGAP), Latissimus dorsi pedicled flap alone or in combination with implant. In some cases even simple implant reconstruction could be offered assuming that the quality of previously irradiated skin has been improved by fat transplants .

Study design: Prospective cohort study

Hypothesis: Reconstruction with BRAVA and fat transplantation is a good alternative to reconstruction with DIEP flap.

Study variables: MRI-based volume estimates, anthropometric measurements, VAS scale (Breast-Q - questionnaire measuring patient-related outcome) and Telemark breast score evaluation through independent investigators

Statistics: Power analysis determine that 25 patients are required in each group in this study considering 80 % power with 95 % significance and 40 % difference with regard to patient satisfaction and early complications.

Follow-up: 6 months after DIEP reconstruction and 3 months after the second session of fat transplantation.

Primary endpoint: assessment of early complications in both study groups

Secondary endpoint: patient satisfaction with shape and symmetry of the breast, Satisfaction with psychosocial, psychological and sexual well-being, satisfaction with process of care, shape of the body and postoperative scars (Breast-Q).

Eligibility criteria: Inclusion Criteria:

1. Women who have consented to participate in the study and underwent mastectomy and radiation therapy.
2. Mammography of the remaining breast performed within 3 months before surgery
3. At least 1 year after completion of radiotherapy
4. BMI between 22 and 32 -

Exclusion Criteria:

1. Patients with recurrent or metastatic breast cancer
2. Patients with pacemakers or metal clips after any surgery
3. Patients with heart, kidney or liver failure or other medical conditions such as severe hypertension, COPD, autoimmune disorders, SLE or poorly regulated diabetes
4. Patients with claustrophobia
5. Patients with severe drug abuse
6. Patients with silicone allergy
7. Patients with bleeding disorders
8. Patients who smoke or have smoked in the last two months

Primary outcomes:
measure: Breast-Q reconstructive module
timeFrame: Change in Breast Q score from preop. status(baseline) to 3 months postop.score for Brava group and 6 months for DIEP group
measure: Early complications
timeFrame: Three months after first two fat grafting sessions in Brava reonstruction group
Secondary outcomes:
measure: Telemark breast score
timeFrame: 3 months after completion of reconstruction for Brava, and 6 months after completion of reconstruction for DIEP-group
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Telemark Hospital
state: Telemark
Study officials:
affiliation: Sykehuset Telemark
name: Hege Kersten, PhD
role: STUDY_DIRECTOR
References: