Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction

Официальное название

Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction：an Open-label, Multicentre, Randomised, Controlled Trial

Обзор

This clinical trial aims to determine whether conventional surgery or endoscopic surgery results in better recovery of breast skin sensation in women with early-stage breast cancer undergoing nipple-sparing mastectomy with prepectoral implant reconstruction. Furthermore, the study will compare the safety, aesthetic outcomes, and quality of life associated with the two surgical approaches. The study seeks to address the following primary research questions: Does conventional surgery lead to superior recovery of breast skin sensation at 6 months postoperatively compared with endoscopic surgery? What are the differences between the two surgical approaches in terms of complication rates, aesthetic outcomes, and patient-reported quality of life? Researchers will compare conventional nipple-sparing mastectomy with endoscopic nipple-sparing mastectomy to determine which procedure better preserves postoperative breast sensation. Participants will: Be randomly assigned to undergo either conventional or endoscopic surgery. Have breast skin sensation measured preoperatively and at multiple postoperative follow-up visits using a standardized assessment tool. Complete validated questionnaires regarding breast satisfaction and quality of life preoperatively and during multiple follow-up visits. Attend scheduled follow-up visits to monitor for complications and to evaluate the long-term appearance and health of the reconstructed breast.

Вмешательства

• Процедура Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction
  This procedure is a traditional surgical approach involving a skin incision made on the breast surface. Under direct visualization, the breast glandular tissue is excised while preserving the nipple-areola complex, followed by a reconstructive surgery with implant placement in the prepectoral plane.
• Процедура Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction
  This minimally invasive procedure is performed through small, concealed incisions in the axilla. Utilizing endoscopic instruments and an imaging system, the breast glandular tissue is resected under video monitoring, followed by reconstructive surgery with implant placement in the prepectoral plane.

Первичные конечные точки

• Average breast sensory thresholds at 6 months post breast reconstruction as measured by Semmes-Weinstein Monofilaments [Срок оценки: 6 months]

Вторичные конечные точки (9)

• Number of participants with postoperative complications as assessed by Clavien-Dindo Classification System within 1 year after surgery [Срок оценки: within 1 year]
• Patient-reported quality of life as measured by Breast-Q reconstruction module [Срок оценки: 6 months and 1 year]
• Physician-assessed breast aesthetic score using a 5-point Likert scale [Срок оценки: 6 months and 1 year]
• Patient-reported quality of life as assessed by E0RTC QLQ-C30 [Срок оценки: 6 months and 1 year]
• Long-term breast skin sensation threshold as measured by Semmes-Weinstein Monofilaments [Срок оценки: Annually up to 10 years]
• Number of participants with postoperative complications as assessed by Clavien-Dindo Classification System after surgery in the long term. [Срок оценки: Annually up to 10 years]
• Long-term physician-assessed breast aesthetic score [Срок оценки: Annually up to 10 years]
• Long-term patient-reported quality of life as measured by Breast-Q reconstruction module [Срок оценки: Annually up to 10 years]
• Long-term patient-reported quality of life as assessed by EORTC-QLQ-C30 [Срок оценки: Annually up to 10 years]

Критерии участия

Критерии включения

• Female patients aged 18 to 70 years.
• Unilateral breast cancer confirmed by preoperative pathology.
• Scheduled to undergo nipple-sparing mastectomy (NSM) with immediate prepectoral implant-based breast reconstruction.
• Invasive carcinoma with a maximum tumor diameter ≤ 5 cm, or ductal carcinoma in situ (DCIS).
• Preoperative imaging assessment confirms a distance of ≥ 1 cm between the lesion and the nipple-areola complex (NAC).
• No clinical, radiological, or pathological evidence of tumor invasion into the NAC, skin, or pectoralis major muscle. The tumor must be confined within the glandular tissue.
• No evidence of distant metastasis (M0).
• Clinically node-negative (cN0) as assessed by preoperative examination.
• No history of neoadjuvant chemotherapy or radiotherapy prior to surgery.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Willing and able to understand the study procedures, provide written informed consent, demonstrate good compliance, and agree to participate in follow-up evaluations.
• The principal surgeon must have experience in performing at least 30 cases of NSM combined with implant-based reconstruction.

Критерии исключения

• Diagnosis of Paget's disease of the breast, recurrent breast cancer, or a history of prior thoracic radiation therapy.
• Evidence of tumor invasion into the skin (including inflammatory breast cancer), nipple-areola complex, or pectoralis major muscle.
• Pregnancy or lactation at the time of enrollment.
• Requirement for re-excision following a prior breast lump biopsy, or a history of any previous breast surgery (including but not limited to augmentation mammoplasty, breast reduction, lumpectomy, etc.).
• Breast size exceeding a D-cup.
• Body mass index (BMI) > 30 kg/m².
• Grade III ptosis (severe breast drooping where the nipple is positioned below the inframammary fold).
• Pre-existing nipple-areolar complex deformities (e.g., nipple inversion, areolar hypoplasia), active skin conditions of the breast (e.g., eczema, dermatitis, infection, ulceration), or significant scarring compromising the surgical site.
• Severe systemic comorbidities (e.g., immunosuppression, uncontrolled diabetes mellitus, severe cardiopulmonary dysfunction, coagulopathy or bleeding diathesis, contraindications to general anesthesia).
• Known hypersensitivity or allergy to silicone gel implants, or to anesthetic agents/antibiotics used perioperatively.
• Pre-existing neurological disorders (e.g., diabetic peripheral neuropathy, Parkinson's disease, polyneuritis, spinal cord injury) or chronic use of medications known to affect neurological/sensory function (e.g., antidepressants, antiepileptics).
• Current heavy smoking (>20 cigarettes per day).
• Current alcohol abuse or substance addiction.
• Concurrent or history of other active malignancies
• Anticipated poor compliance with follow-up protocols or inability to complete scheduled postoperative evaluations.

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

Список центров уточняется — проверьте первичный протокол.

Публикации

• Kim JH, Ryu JM, Bae SJ, Ko BS, Choi JE, Kim KS, Cha C, Choi YJ, Lee HY, Nam SE, Kim Z, Kang YJ, Lee MH, Lee JE, Park E, Shin HJ, Kim MK, Choi HJ, Kwon SU, Son NH, Park HS, Lee J; Korea Robot-endoscopy Minimal Access Breast Surgery Study Group. Minimal Access vs Conventional Nipple-Sparing Mastectomy. JAMA Surg. 2024 Oct 1;159(10):1177-1186. doi: 10.1001/jamasurg.2024.2977. PMID 39141399
• Hammond JB, Kandi LA, Armstrong VL, Kosiorek HE, Rebecca AM, Casey WJ 3rd, Kruger EA, Cronin PA, Pockaj BA, Teven CM. Long-term breast and nipple sensation after nipple-sparing mastectomy with implant reconstruction: Relevance to physical, psychosocial, and sexual well-being. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):2914-2919. doi: 10.1016/j.bjps.2022.06.034. Epub 2022 Jun 20. PMID 35915018
• Lai HW, Chang YL, Chandrachamnong K, See MH, Huang HI, Lin SL, Fang DY, Chen ST, Chen DR, Mok CW, Cheng FT. Factors associated with alteration of nipple or skin sensation and impact of duration of time following nipple-sparing mastectomy (NSM): an analysis of 460 cases with comparison of conventional versus endoscopic- or robotic-assisted NSM. World J Surg Oncol. 2023 Jul 26;21(1):222. doi: 10.118 PMID 37491239
• Zhou J, Xie Y, Liang F, Feng Y, Yang H, Qiu M, Zhang Q, Chung K, Dai H, Liu Y, Liang P, Du Z. A novel technique of reverse-sequence endoscopic nipple-sparing mastectomy with direct-to-implant breast reconstruction: medium-term oncological safety outcomes and feasibility of 24-h discharge for breast cancer patients. Int J Surg. 2024 Apr 1;110(4):2243-2252. doi: 10.1097/JS9.0000000000001134. PMID 38348883
• Seth AK, Sisco M. Prepectoral Breast Reconstruction. Plast Reconstr Surg. 2025 Jan 1;155(1):213e-227e. doi: 10.1097/PRS.0000000000011737. Epub 2024 Dec 16. PMID 39700251

Идентификаторы

NCT: NCT07372339 · NJMU-BC11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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