Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction

Recruiting

• Conditions: Nipple-sparing Mastectomy; Immediate Prosthesis Reconstruction; Endoscopic Surgery; Robotic Surgery

• Registration Number: NCT06748677
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-27
• Status Verified: 2025-01
• Study Start: 2025-01-03
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07
• Primary Completion: 2028-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 484

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of postoperative complications	3 months	Delayed wound healing, nipple and areola ischemia/necrosis, skin ischemia/necrosis, serum swelling, wound dehiscence/prosthesis exposure, infection, and prosthesis removal occurred within 3 months after surgery.

Secondary Outcome Measures

Name	Time	Method
Patient-reported Outcome Measures	1 year	BREAST-Q scores, higher scores mean a better outcome
local-regional recurrence	5 years	From research enrollment to ipsilateral breast skin, subcutaneous, chest wall, axillary, internal mammary, and supraclavicular lymph node recurrence;
Distant metastasis free survival	5 years	the time from enrollment in the study to the occurrence of distant recurrence and metastasis;
Disease free survival	5 years	the time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China