Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients

Официальное название

Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Patients

Обзор

The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following mastectomy. It will also evaluate patient satisfaction, quality of life, complication rates, and cost-effectiveness of both reconstruction techniques. The main questions it aims to answer are: Does AFT result in non-inferior patient satisfaction with the reconstructed breast compared to DIEP flap reconstruction 12 months after the final operation? Does AFT result in fewer major complications and improved cost-effectiveness compared to DIEP flap reconstruction? Are quality of life outcomes and oncologic safety comparable between AFT and DIEP flap reconstruction in irradiated patients? Researchers will compare AFT to DIEP flap reconstruction to see if AFT can provide similar reconstructive outcomes with lower morbidity and fewer complications in irradiated breast cancer patients. Participants will: Undergo breast reconstruction using either AFT or DIEP flap reconstruction Attend follow-up visits for clinical examinations, imaging, and assessment of complications Complete questionnaires about breast satisfaction, quality of life, and recovery during follow-up Be monitored for oncologic safety and reconstructive outcomes for 12 months after the final operation

Вмешательства

• Процедура Autologous fat transfer
  Autologous fat transfer as total breast reconstruction
• Процедура Deep inferior epigastric perforator flap
  Deep inferior epigastric perforator flap as breast reconstruction

Первичные конечные точки

• to determine whether autologous fat transfer (AFT) is non-inferior to DIEP flap breast re-construction regarding breast satisfaction, as measured by the BREAST-Q, 12 months after the final reconstructive procedure in irradiated breast cancer patients; [Срок оценки: 12 months]
• to assess whether AFT is superior to DIEP flap reconstruction in terms of the incidence of major complications requiring reoperation or hospital readmission. [Срок оценки: 12 months]
• cost-effectiveness of AFT compared with DIEP flap reconstruction will be evaluated. [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Physical Well-being: Abdomen (BREAST-Q) [Срок оценки: 12 months]
• Complications (Minor & General) [Срок оценки: 12 months]
• Oncologic Safety [Срок оценки: 12 months]
• Sensory Recovery [Срок оценки: 12 months]
• Physical Function and Pain [Срок оценки: 12 months]
• Breast Aesthetics & Volume [Срок оценки: 12 months]
• Radiation-Associated Changes [Срок оценки: 12 months]
• Physical Well-being: Chest (BREAST-Q) [Срок оценки: 12 months]
• Sexual Well-being (BREAST-Q) [Срок оценки: 12 months]
• Breast Sensation (BREAST-Q) [Срок оценки: 12 months]
• Donor Site Satisfaction (BODY-Q) [Срок оценки: 12 months]
• Adverse Effects of Radiation (BREAST-Q) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Female, aged >18 years.
• BMI between > 22 and <35 kg/m2
• History of breast cancer treated with mastectomy (minimally 3 months after mastec-tomy) and post mastectomy chest wall radiotherapy (completed ≥6 months before en-rollment).
• May include contralateral/bilateral prophylactic mastectomy if at least one side had cancer and radiation.
• Desires autologous breast reconstruction and accepts randomization between AFT and DIEP.
• Medically fit for surgery (ASA I-III).
• Sufficient donor tissue for both AFT (enough fat) and DIEP (suitable abdominal tissue and vasculature).
• No evidence of active cancer at enrollment; remission confirmed.
• Able to wear the EVE device (if randomized in AFT).
• Capable of understanding study information and questionnaires (Dutch or English), willing to give informed consent, and able to comply with follow-up.

Критерии исключения

• Prior autologous breast reconstruction on the intended side. BMI <22 or >35 kg/m2
• Contraindication to DIEP flap (e.g., prior abdominoplasty or abdominal scars affecting perforators).
• Contraindication to AFT (e.g., insufficient fat or conditions impairing fat graft viability).
• Current chemotherapy or completed less than 4 weeks prior to enrollment.
• Serious uncontrolled comorbidities making elective surgery unsafe (e.g., unstable heart disease, severe coagulopathy, end-stage organ failure).
• Active smoker or not abstinent for at least 6 weeks pre-operatively.
• Pregnant at time of enrollment.
• In case low compliance is expected or an inability to comply with study protocol, including unwillingness to undergo either AFT or DIEP, or inability to complete follow-up (due to language, cognitive issues, or relocation plans).
• Previous enrollment in this trial (patients can only be included once, even if later presenting for contralateral reconstruction).
• Allergy to lidocaine or silicone

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• AzM — Maastricht

Идентификаторы

NCT: NCT07641985 · NL-010887 · 2025008144

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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