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
NCT ID: NCT07037537
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
26 participants
INTERVENTIONAL
2024-10-30
2026-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation
Endoscopic assisted NSM+prosthesis combined with patch for anterior breast reconstruction and simultaneous fat transplantation
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. 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;
3. Patients undergoing preventive mastectomy are not allowed to be included in the study;
4. 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;
5. 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);
6. Sentinel lymph node biopsy negative;
7. Patients with low load positive axillary lymph nodes (isolated tumor cells, micro or macro metastases), but exempted from adjuvant radiotherapy after surgery;
8. 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;
9. The volume of the prosthesis is less than 500cc;
10. 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;
11. ECOG score 0-1 points;
12. New adjuvant chemotherapy patients are allowed to be enrolled;
13. No smoking history or quitting smoking for at least 4 weeks;
14. The researcher determines that they are able to comply with the research protocol;
15. 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;
16. After obtaining sufficient information, voluntarily participate and sign an informed consent form.
Exclusion Criteria
2. Double breast cancer;
3. Bilateral breast reconstruction patients;
4. Patients who have undergone fat injection, breast augmentation with implants, and breast reduction surgery in the past;
5. Patients with incomplete immune function, poor control of diabetes and active smoking;
6. Patients with severe breast sagging;
7. Breast cup size ≥ E;
8. Accept two-step breast reconstruction using dilators/prostheses, autologous breast reconstruction, and breast reconstruction performed through open surgery;
9. Patients who have previously received and/or received postoperative radiotherapy for the reconstruction site or chest wall;
10. Patients who plan to undergo symmetrical surgery on the healthy breast during the visit period;
11. Patients with mental illnesses or abnormalities who are expected to be unable to independently complete the BREAST-Q scale;
12. Pregnant and lactating patients;
13. Poor compliance, unable to conduct relevant examinations and follow ups according to the trial requirements;
14. 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.
18 Years
70 Years
FEMALE
No
Sponsors
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Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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xiuchun chen
Role: STUDY_DIRECTOR
Henan Cancer Hospital
Locations
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Henan Cancer Hospital
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Mok CW, Lai HW. Endoscopic-assisted surgery in the management of breast cancer: 20 years review of trend, techniques and outcomes. Breast. 2019 Aug;46:144-156. doi: 10.1016/j.breast.2019.05.013. Epub 2019 May 20.
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.
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.
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.
Ostapenko E, Nixdorf L, Devyatko Y, Exner R, Wimmer K, Fitzal F. Prepectoral Versus Subpectoral Implant-Based Breast Reconstruction: A Systemic Review and Meta-analysis. Ann Surg Oncol. 2023 Jan;30(1):126-136. doi: 10.1245/s10434-022-12567-0. Epub 2022 Oct 16.
Rancati AO, Angrigiani CH, Hammond DC, Nava MB, Gonzalez EG, Dorr JC, Gercovich GF, Rocco N, Rostagno RL. Direct to Implant Reconstruction in Nipple Sparing Mastectomy: Patient Selection by Preoperative Digital Mammogram. Plast Reconstr Surg Glob Open. 2017 Jun 20;5(6):e1369. doi: 10.1097/GOX.0000000000001369. eCollection 2017 Jun.
Sigalove S. Prepectoral breast reconstruction and radiotherapy-a closer look. Gland Surg. 2019 Feb;8(1):67-74. doi: 10.21037/gs.2019.01.01.
Sorrentino L, Regolo L, Scoccia E, Petrolo G, Bossi D, Albasini S, Caruso A, Vanna R, Morasso C, Mazzucchelli S, Truffi M, Corsi F. Autologous fat transfer after breast cancer surgery: An exact-matching study on the long-term oncological safety. Eur J Surg Oncol. 2019 Oct;45(10):1827-1834. doi: 10.1016/j.ejso.2019.05.013. Epub 2019 May 21.
Gronovich Y, Winder G, Maisel-Lotan A, Lysy I, Sela E, Spiegel G, Carmon M, Hadar T, Elami A, Eizenman N, Binenboym R. Hybrid Prepectoral Direct-to-Implant and Autologous Fat Graft Simultaneously in Immediate Breast Reconstruction: A Single Surgeon's Experience with 25 Breasts in 15 Consecutive Cases. Plast Reconstr Surg. 2022 Mar 1;149(3):386e-391e. doi: 10.1097/PRS.0000000000008879.
Other Identifiers
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2024-362
Identifier Type: -
Identifier Source: org_study_id
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