Evaluation of the Effectiveness and Safety of Laparoscopic Assisted Mastectomy With Preservation of Nipple and Areola, Immediate One-step Breast Reconstruction With Pectoral Muscle Prosthesis and Patch, and Simultaneous Autologous Fat Transplantation

Официальное название

To Evaluate the Efficacy and Safety of Laparoscopic-assisted Nipple-areola-sparing Mastectomy Plus Pectoral Anterior Prosthesis Plus Mesh Immediate One-step Breast Reconstruction Plus Concurrent Autologous Fat Grafting: a Prospective, Single-centre, Single-arm Study

Обзор

Evaluation of the effectiveness and safety of laparoscopic assisted breast resection with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch for immediate one-step breast reconstruction and concurrent autologous fat transplantation in a prospective study

Подробное описание

This study is a prospective, single center, single arm clinical trial. It is planned to recruit 29 patients with unilateral breast cancer of cT1-2N0M0. Patients who meet the inclusion criteria are planned to undergo laparoscopic assisted NSM+prosthesis combined with patch breast reconstruction and concurrent fat transplantation surgery.

Main endpoint of the study: incidence of severe complications after breast reconstruction surgery.

Secondary study endpoints: BREAST-Q (Breast Reconstruction Module) score, breast reconstruction success rate, incidence of all complications, physician evaluated breast cosmetic outcomes, occurrence of capsule contractures, nipple areola and breast skin sensation, and tumor safety.

Вмешательства

• Процедура Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation
  Laparoscopic assisted mastectomy with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch, immediate one-step breast reconstruction and simultaneous autologous fat transplantation

Первичные конечные точки

• Incidence of serious complications after breast reconstruction surgery [Срок оценки: One week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery]

Вторичные конечные точки (7)

• BREAST-Q (Breast Reconstruction Module) score [Срок оценки: BREAST-Q scoring was performed at preoperative, postoperative 1-month, 3-month, 6-month, and 12-month follow-up]
• Success rate of breast reconstruction [Срок оценки: One year after surgery]
• All incidence of complications [Срок оценки: On the day of surgery, one week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery]
• Breast cosmetic effects evaluated by doctors [Срок оценки: Before surgery，on the day of surgery, one months after surgery,three months after surgery, six months after surgery, and one year after surgery]
• Occurrence of capsule contraction [Срок оценки: one months after surgery,three months after surgery, six months after surgery, and one year after surgery]
• Nipple, areola, and breast skin sensation [Срок оценки: Before surgery, one week after surgery, one months after surgery,three months after surgery, six months after surgery, and one year after surgery]
• Tumor safety [Срок оценки: five years after surgery]

Критерии участия

Критерии включения

• Women aged 18 to 70 years old;
• In the first diagnosis of unilateral breast cancer patients, the maximum diameter of invasive tumor is ≤ 5cm, and there is no requirement for tumor size of carcinoma in situ in principle;
• Patients undergoing preventive mastectomy are not allowed to be included in the study;
• Clinical examination and auxiliary examinations suggest that the tumor is confined to the mammary gland and has not invaded the nipple areola complex, skin, or chest wall;
• Clinical axillary lymph node negative (clinical physical examination and imaging suggest negative axillary lymph nodes; for suspected positive axillary lymph nodes, fine needle aspiration or hollow needle biopsy is required to confirm negative);
• Sentinel lymph node biopsy negative;
• Patients with low load positive axillary lymph nodes (isolated tumor cells, micro or macro metastases), but exempted from adjuvant radiotherapy after surgery;
• Patients who are not suitable for breast conserving surgery or who are unwilling to undergo breast conserving surgery and plan to undergo laparoscopic assisted mastectomy with preservation of the nipple and areola, as well as immediate one-step breast reconstruction with a breast prosthesis combined with a chest muscle prosthesis and simultaneous fat transplantation; If frozen pathology or routine pathology indicates a positive posterior margin of the nipple, it is allowed to remove the nipple, but the areola must be preserved;
• The volume of the prosthesis is less than 500cc;
• During the observation period of the study, the affected side may consider re fat injection, but symmetrical surgery is not allowed on the healthy side;
• ECOG score 0-1 points;
• New adjuvant chemotherapy patients are allowed to be enrolled;
• No smoking history or quitting smoking for at least 4 weeks;
• The researcher determines that they are able to comply with the research protocol;
• Those who participate in other clinical trials (including intervention or non intervention studies) at the same time and are judged by the researchers to not affect the study protocol can be enrolled normally;
• After obtaining sufficient information, voluntarily participate and sign an informed consent form.

Критерии исключения

• Specialized physical examination and/or auxiliary examination suggest that the tumor involves the nipple areola complex (including Paget's disease) or the skin;
• Double breast cancer;
• Bilateral breast reconstruction patients;
• Patients who have undergone fat injection, breast augmentation with implants, and breast reduction surgery in the past;
• Patients with incomplete immune function, poor control of diabetes and active smoking;
• Patients with severe breast sagging;
• Breast cup size ≥ E;
• Accept two-step breast reconstruction using dilators/prostheses, autologous breast reconstruction, and breast reconstruction performed through open surgery;
• Patients who have previously received and/or received postoperative radiotherapy for the reconstruction site or chest wall;
• Patients who plan to undergo symmetrical surgery on the healthy breast during the visit period;
• Patients with mental illnesses or abnormalities who are expected to be unable to independently complete the BREAST-Q scale;
• Pregnant and lactating patients;
• Poor compliance, unable to conduct relevant examinations and follow ups according to the trial requirements;
• Suffering from serious accompanying diseases or other comorbidities that may interfere with planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Henan Cancer Hospital — Чжэнчжоу

Публикации

• Kraenzlin F, Chopra K, Kokosis G, Venturi ML, Mesbahi A, Nahabedian MY. Revision Breast Reconstruction with Prepectoral Pocket Conversion of Submuscular Breast Implants. Plast Reconstr Surg. 2021 May 1;147(5):743e-748e. doi: 10.1097/PRS.0000000000007885. PMID 33890886
• Chatterjee A, Nahabedian MY, Gabriel A, Macarios D, Parekh M, Wang F, Griffin L, Sigalove S. Early assessment of post-surgical outcomes with pre-pectoral breast reconstruction: A literature review and meta-analysis. J Surg Oncol. 2018 May;117(6):1119-1130. doi: 10.1002/jso.24938. Epub 2018 Jan 18. PMID 29346711
• Li Y, Xu G, Yu N, Huang J, Long X. Prepectoral Versus Subpectoral Implant-Based Breast Reconstruction: A Meta-analysis. Ann Plast Surg. 2020 Oct;85(4):437-447. doi: 10.1097/SAP.0000000000002190. PMID 31913902
• Feng Y, Liang F, Wen N, Yang H, Zhou J, Zhang S, Liu X, Qiu M, Xie Y, Du Z. An Innovative and Highly Efficient Single-Port Endoscopic Nipple-/Skin-Sparing Mastectomy and Dual-Plane Direct-to-Implant Breast Reconstruction: A Prospective Study from a Single Institution. Aesthetic Plast Surg. 2024 Mar;48(6):1133-1141. doi: 10.1007/s00266-023-03402-2. Epub 2023 May 30. PMID 37253841
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• Wang ZH, Gao GX, Liu WH, Wu SS, Xie F, Xu W, Ding GQ, Xu YQ, Zhang ZT, Qu X. Single-port nipple-sparing subcutaneous mastectomy with immediate prosthetic breast reconstruction for breast cancer. Surg Endosc. 2023 May;37(5):3842-3851. doi: 10.1007/s00464-023-09862-6. Epub 2023 Jan 25. PMID 36695902
• Li L, Su Y, Xiu B, Huang X, Chi W, Hou J, Zhang Y, Tian J, Wang J, Wu J. Comparison of prepectoral and subpectoral breast reconstruction after mastectomies: A systematic review and meta analysis. Eur J Surg Oncol. 2019 Sep;45(9):1542-1550. doi: 10.1016/j.ejso.2019.05.015. Epub 2019 May 14. PMID 31256950
• Abbate O, Rosado N, Sobti N, Vieira BL, Liao EC. Meta-analysis of prepectoral implant-based breast reconstruction: guide to patient selection and current outcomes. Breast Cancer Res Treat. 2020 Aug;182(3):543-554. doi: 10.1007/s10549-020-05722-2. Epub 2020 Jun 9. PMID 32514624

Идентификаторы

NCT: NCT07037537 · 2024-362

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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