Clinical trial NCT06748677: Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction
Official title: Prospective Cohort Study of Minimally Invasive Surgery Versus Traditional Open Surgery for Nipple Areola Preserving Mastectomy Combined with Immediate Prosthesis Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nipple-sparing Mastectomy
Immediate Prosthesis Reconstruction
Endoscopic Surgery
Robotic Surgery
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 484
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective inclusion of patients who underwent minimally invasive surgery (endoscopic and robotic surgey) and conventional surgery at Peking University People's Hospital from January 1, 2025.01 to December 31, 2028.12 to preserve the NSM with immediate prosthesis breast reconstruction

Brief summary: Breast cancer is the most common malignant tumor in women. Surgical treatment is the most important treatment for early breast cancer. Breast cancer resection is considered to be a destructive operation. Patients need to accept the double blow of physical and psychological loss of breast shape. Although with the change of the concept of early diagnosis and treatment of breast cancer, the breast conserving rate of breast cancer is gradually increasing in China, more than half of the patients are still unable to retain breast due to their condition. For these patients, breast reconstruction surgery is an important means to improve the postoperative breast shape. With the improvement of surgical technology, endoscopic/robotic NSM combined with immediate prosthesis breast reconstruction has been gradually developed. According to previous literature reports, it has good tumor safety and aesthetics, but it is still lack of large-scale prospective results.

This project plans to adopt a prospective cohort design, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and prospectively include patients who receive NSM combined with immediate prosthesis reconstruction under endoscopy/robot and conventional surgery from January 1, 2025 to December 31, 2028. The perioperative complications, tumor safety and patient reported outcomes of the two methods were compared.


Eligibility criteria: Inclusion Criteria:

1. Underwent surgical treatment at Peking University People's Hospital, with hospitalization records;
2. Preoperative core needle biopsy confirmed breast cancer;
3. The clinical stage of the tumor is stage 0-IIIB; 4）cT≤5cm， cN0/cN1，M0， And there is no tumor invasion of the nipple areola complex, skin, and chest wall;

5) Intraoperative plan to use non biological patches (such as TiLoop) to partially or completely wrap the prosthesis 6) Signed agreement to participate in this study; 7) Can cooperate to complete the Patient Reported Outcome Measures (PROMs) questionnaire.

Exclusion Criteria:

1. Lack of clinical pathological data (such as imaging data, pathological data);
2. Pregnancy or lactation period;
3. Patients with metastatic breast cancer or bilateral breast cancer;
4. Have undergone breast conserving surgery/chest radiation therapy before;
5. Patients with nipple areola invasion and subsequent removal of nipple areola complex;
6. Failed to undergo curative surgery;

Primary outcomes:
measure: incidence of postoperative complications
timeFrame: 3 months
Secondary outcomes:
measure: Patient-reported Outcome Measures
timeFrame: 1 year
measure: local-regional recurrence
timeFrame: 5 years
measure: Distant metastasis free survival
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
Other outcomes:
measure: tumour saftey
timeFrame: 1 week
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: