Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction (EnRoNSM)

Prospective Cohort Study of Minimally Invasive Surgery Versus Traditional Open Surgery for Nipple Areola Preserving Mastectomy Combined with Immediate Prosthesis Reconstruction

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 484

Contacts and Locations

• Study Contact: Name: yuan peng, doctor; Phone Number: 86+13671287670; Email: 13671287670@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: yuan peng, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
endoscopic and robotic surgery; nipple-sparing mastectomy under endoscopic/robotic surgery combined with immediate prosthesis reconstruction
conventional surgery; conventional nipple-sparing mastectomy combined with immediate prosthesis reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postoperative complications	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	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.	5 years
local-regional recurrence	From research enrollment to ipsilateral breast skin, subcutaneous, chest wall, axillary, internal mammary, and supraclavicular lymph node recurrence;	5 years
Distant metastasis free survival	the time from enrollment in the study to the occurrence of distant recurrence and metastasis;	5 years
Patient-reported Outcome Measures	BREAST-Q scores, higher scores mean a better outcome	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
tumour saftey	Pathology of residual cavity lavage fluid; Pathology of peripheral edge tissue in breast specimens. If we can see tumour cell in the lavage fluid or breast tissue on the peripheral edge means not safety.	1 week

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PKUPH2024Z217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No