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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05833659
Other study ID # RESPECT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date March 2027

Study information

Verified date April 2023
Source Beijing Friendship Hospital
Contact guoxuan gao, MD
Phone +861063138712
Email aliceggx@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date March 2027
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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


Intervention

Procedure:
The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction

Locations

Country Name City State
China Beijing Friendship Hospital, Capital medical University Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Beijing Friendship Hospital Beijing Health Promotion Association

Country where clinical trial is conducted

China, 

Outcome

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