Actively Recruiting
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
Led by Henan Cancer Hospital · Updated on 2025-06-25
26
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- First diagnosis of unilateral breast cancer with invasive tumor size 5 cm or less
- Tumor confined to the breast without invasion of nipple areola complex, skin, or chest wall
- Clinical axillary lymph nodes negative or confirmed negative by biopsy if suspected
- Negative sentinel lymph node biopsy
- Low load positive axillary lymph nodes allowed if no adjuvant radiotherapy planned
- Unsuitable or unwilling for breast conserving surgery, opting for laparoscopic assisted mastectomy with nipple and areola preservation and immediate reconstruction
- Prosthesis volume less than 500cc
- Possibility of additional fat injections on affected side allowed; no surgery on healthy side
- ECOG performance status 0-1
- New adjuvant chemotherapy patients allowed
- Non-smokers or quit smoking at least 4 weeks prior
- Able to comply with study protocol
- Participation in other clinical trials allowed if not affecting this study
- Voluntary informed consent provided
You will not qualify if you...
- Tumor involving nipple areola complex or skin, including Paget's disease
- Bilateral breast cancer
- Patients undergoing bilateral breast reconstruction
- Previous breast fat injection, implants, or reduction surgery
- Immunodeficiency, poorly controlled diabetes, or active smoking
- Severe breast sagging
- Breast cup size E or larger
- Planned two-step reconstruction or autologous reconstruction or open surgery
- Previous or planned postoperative radiotherapy to reconstruction site or chest wall
- Planned symmetrical surgery on healthy breast during study
- Mental illness preventing completion of BREAST-Q questionnaire
- Pregnant or breastfeeding
- Poor compliance or inability to attend exams and follow-ups
- Serious comorbid diseases or other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
X
xiuchun Chen
CONTACT
M
minhao Lv
CONTACT
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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