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

NCT07037537 | Recruiting

• 1 other identifier: 2024-362
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer Patients

Keywords

Breast cancer; Endoscopic technology; Breast reconstruction surgery; Autologous fat transplantation

Outcome Measures

Primary Outcomes (1)

• Incidence of serious complications after breast reconstruction surgery

  All surgical related complications (including hematoma, poor wound healing, skin flap necrosis, infection, incision dehiscence, fat injection related complications, etc.) are classified according to the Clavien Dindo scoring system. The Clavien Dindo grading system is based on the severity of postoperative complications and whether corresponding treatment is needed for the complications. Postoperative complications are classified into grades I-V, and those classified as grade III or above by Clavien Dindo are considered serious complications.

  One week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery

Secondary Outcomes (7)

• BREAST-Q (Breast Reconstruction Module) score

  BREAST-Q scoring was performed at preoperative, postoperative 1-month, 3-month, 6-month, and 12-month follow-up

• Success rate of breast reconstruction

  One year after surgery

• All incidence of complications

  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

  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

  one months after surgery,three months after surgery, six months after surgery, and one year after surgery

Study Arms (1)

Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation

EXPERIMENTAL

Endoscopic assisted NSM+prosthesis combined with patch for anterior breast reconstruction and simultaneous fat transplantation

Procedure: Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation

Interventions

Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation PROCEDURE

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

Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Related Publications (13)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 31176887 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 36245049 RESULT

• 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.

  PMID: 28740781 RESULT

• 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.

  PMID: 30842930 RESULT

• 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.

  PMID: 31133371 RESULT

• 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.

  PMID: 35196670 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• xiuchun chen

  Henan Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

xiuchun Chen

CONTACT

18603719919; cxc701024@163.com

minhao Lv

CONTACT

13838392355; zlyylvminhao2789@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: October 30, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2024-10

Locations

CN (1)