Revision Breast Reconstruction with Prepectoral Pocket Conversion of Submuscular Breast Implants.
Franca Kraenzlin, Karan Chopra, George Kokosis...
https://pubmed.ncbi.nlm.nih.gov/33890886Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
FEMALE
ID07037537
Evaluation of Laparoscopic-assisted Nipple-areola-sparing Mastectomy with Immediate One-step Breast Reconstruction Using Pectoral Muscle Prosthesis and Patch plus Simultaneous Autologous Fat Grafting
Led by Henan Cancer Hospital · Updated on 2025-06-25
26
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of a specific breast cancer surgery approach for women diagnosed with unilateral breast cancer. The study focuses on laparoscopic assisted mastectomy that preserves the nipple and areola, combined with immediate breast reconstruction using a chest muscle prosthesis and patch, along with simultaneous autologous fat transplantation. The study is designed as a prospective, single-center, single-arm clinical trial enrolling patients with early-stage breast cancer. Participants will undergo laparoscopic assisted nipple-sparing mastectomy followed by immediate one-step breast reconstruction using a prosthesis combined with a chest muscle patch and concurrent fat transplantation. This procedure is performed as a single combined surgery without a comparator group. The study includes follow-up periods to monitor outcomes and any complications over time. During the study, participants will be monitored for serious complications at several time points up to one year after surgery. Additional assessments include breast reconstruction success rates, cosmetic outcomes evaluated by physicians, breast and nipple sensation, occurrence of capsule contractures, and tumor safety over five years. Patient-reported outcomes are measured using the BREAST-Q questionnaire before and after surgery at multiple intervals. The total observation includes follow-ups from surgery day up to five years for tumor safety assessment.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 18Years - 70Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years old
- First diagnosis of unilateral breast cancer with invasive tumor 5 cm or less
- Tumor confined to breast, no involvement of nipple, areola, skin, or chest wall
- Clinically negative axillary lymph nodes confirmed by biopsy if suspected
- Negative sentinel lymph node biopsy
- Low load positive axillary lymph nodes allowed if no adjuvant radiotherapy planned
- Not suitable or unwilling for breast conserving surgery and planning laparoscopic assisted mastectomy with immediate reconstruction
- Prosthesis volume less than 500cc
- May consider repeat fat injection on affected side during study, no surgery on healthy side
- ECOG performance status 0-1
- New adjuvant chemotherapy patients allowed
- No current smoking or quit smoking at least 4 weeks prior
- Able to comply with study protocol
- May participate in other trials if not affecting this study
- Voluntary informed consent obtained
You will not qualify if you...
- Tumor involving nipple-areola complex or skin, including Paget's disease
- Bilateral breast cancer
- Prior bilateral breast reconstruction
- Previous breast fat injection, implants, or reduction surgery
- Immune dysfunction, poorly controlled diabetes, or active smoking
- Severe breast sagging
- Breast cup size E or larger
- Planned two-step breast reconstruction or autologous/open surgery reconstruction
- Prior or planned radiotherapy to reconstruction site or chest wall
- Planned symmetrical surgery on healthy breast during study
- Mental illness preventing completion of BREAST-Q
- Pregnancy or lactation
- Poor compliance or inability to complete required exams and follow-ups
- Serious comorbidities interfering with treatment or study participation as judged by researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
Participants undergo laparoscopic assisted mastectomy with preservation of nipple and areola, immediate one-step breast reconstruction using pectoral muscle prosthesis and patch, and simultaneous autologous fat transplantation. Immediate post-operative care is provided following surgery.
1 visit (in-person)
Post-operative Follow-up
Duration - One week to one year after surgery
Participants are monitored for complications, breast reconstruction success, cosmetic outcomes, capsule contracture occurrence, and nipple, areola, and breast skin sensation through several follow-up visits.
Visits at one week, one month, three months, six months, and one year after surgery
Long-term Monitoring
Duration - Five years after surgery
Participants are monitored for tumor safety outcomes over an extended period after surgery.
Periodic assessments during the five-year follow-up
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
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Research Team
X
xiuchun Chen
M
minhao Lv
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Yunzhu Li, Gang Xu, Nanze Yu...
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Zi-Han Wang, Guo-Xuan Gao, Wei-Hua Liu...
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Olivia Abbate, Nikki Rosado, Nikhil Sobti...
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Edvin Ostapenko, Larissa Nixdorf, Yelena Devyatko...
https://pubmed.ncbi.nlm.nih.gov/36245049Direct to Implant Reconstruction in Nipple Sparing Mastectomy: Patient Selection by Preoperative Digital Mammogram.
Alberto O Rancati, Claudio H Angrigiani, Dennis C Hammond...
https://pubmed.ncbi.nlm.nih.gov/28740781