Comparison Between Prepectoral and Subpectoral Breast Reconstruction

Trial Title: Comparison Between Prepectoral and Subpectoral Breast Reconstruction

NCT ID: NCT05833659

Condition: Stage II Breast Cancer
Stage I Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
breast cancer
endoscopic nipple-sparing mastectomy
breast reconstruction
breast satisfaction
BREAST-Q score

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Other

Intervention:

Intervention type: Procedure
Intervention name: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
Description: Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction
Arm group label: The prepectoral breast reconstruction
Arm group label: The subpectoral breast reconstruction

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.

Criteria for eligibility:

Study pop:
Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) and having willingness for breast reconstruction.

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Beijing Friendship Hospital, Capital medical University

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: guoxuan Guo

Phone: +861063138712
Email: aliceggx@163.com

Start date: March 1, 2022

Completion date: March 2027

Lead sponsor:
Agency: Beijing Friendship Hospital
Agency class: Other

Collaborator:
Agency: Beijing Health Promotion Association
Agency class: Other

Source: Beijing Friendship Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05833659