Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction

NCT ID: NCT06748677

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 484 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-03
• Study Completion Date: 2031-12-31

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.

Conditions

Nipple-sparing Mastectomy; Immediate Prosthesis Reconstruction; Endoscopic Surgery; Robotic Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

endoscopic and robotic surgery

nipple-sparing mastectomy under endoscopic/robotic surgery combined with immediate prosthesis reconstruction

No interventions assigned to this group

conventional surgery

conventional nipple-sparing mastectomy combined with immediate prosthesis reconstruction

No interventions assigned to this group

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;

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shu Wang

director of breast center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

yuan peng, doctor

Role: CONTACT

13671287670@163.com

86+13671287670

Facility Contacts

yuan peng, doctor

Role: primary

Other Identifiers

PKUPH2024Z217

Identifier Type: -

Identifier Source: org_study_id