Comparison Between Prepectoral and Subpectoral Breast Reconstruction

Recruiting

• Conditions: Stage II Breast Cancer; Stage I Breast Cancer
• Interventions: Procedure: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy

• Registration Number: NCT05833659
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. The study's primary objective is to compare single-port endoscopic NSM combined with pre-pectoral breast reconstruction to the subpectoral breast reconstruction group regarding breast satisfaction.

This study is an ambispective cohort study. The study will be conducted at Beijing Friendship Hospital, affiliated with Capital Medical University. Patients will be enrolled retrospectively from January 2014 to March 2022 by reviewing the medical records and recruited prospectively from March 2022 to March 2025. The two cohorts are the pre-pectoral breast reconstruction cohort and the subpectoral breast reconstruction cohort, both following single-port insufflation endoscopic nipple-sparing mastectomy. The primary outcome of this study is postoperative breast satisfaction, which the BREAST-Q score will measure. The different variables will be compared using the Χ2 test for categorical variables and the Mann-Whitney test for continuous variables.

Detailed Description

Sample size and statistical analysis This study is an ambispective cohort study. According to the previous retrospective research data of the center, the breast satisfaction score is the main research object. The standard deviation was 2.6, the non-inferiority margin was 0.15, the test level was α=0.05, β=0.2, and a one-sided test was performed. Eighty patients will be needed for two cohorts in a 1:1 ratio. Considering the 10% loss to follow-up rate, 44 patients will be required to be enrolled in each group.

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-16
• Study First Submitted QC: 2023-04-16
• Last Update Submitted: 2023-04-16
• Study First Posted: 2023-04-27
• Last Update Posted: 2023-04-27
• Primary Completion: 2025-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

1. Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy.
2. Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy.
3. Patients having willingness for breast reconstruction.
4. Age between 18 to 70 years.
5. Maximum diameter of the cancer lesion ≤ 3 cm.
6. Physical examination and breast magnetic resonance imaging (MRI) confirmed that the tumor did not invade the skin, subcutaneous tissue, or chest wall.
7. The distance between the lesion and the nipple is ≥2 cm, and it is confirmed by physical examination and MRI that the nipple-areola complex is not invaded.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 to 2.

Exclusion Criteria

1. patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months.
2. Having history of malignant tumor (s) within 5 years.
3. Patients under immunosuppressive therapy for organ transplantation.
4. Having continuous systemic steroid hormone therapy.
5. Pregnant or lactating women.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The subpectoral breast reconstruction	The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy	The patients received subpectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy
The prepectoral breast reconstruction	The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy	The patients received prepectoral breast reconstruction after single-port insufflation endoscopic nipple-sparing mastectomy

Primary Outcome Measures

Name	Time	Method
breast satisfaction	12 months after operation	measured by BREAST-Q score

Secondary Outcome Measures

Name	Time	Method
Animation deformity	12 months after operation	confirmed by the doctor's physical examination
Adverse events	within 30 days after surgery	according to Clavien-Dindo system
Physical well-being of chest	12 months after operation	measured by BREAST-Q score
Local recurrence and distant metastasis of breast cancer	12 months after operation	physical examination or imaging examination with histologically confirmed

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital medical University; 🇨🇳 Beijing, Beijing, China