Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction

NCT06748677 | Recruiting

• 1 other identifier: PKUPH2024Z217
• Study Type: observational
• Target: 484
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient-reported Outcome Measures

  1 year

• local-regional recurrence

  5 years

• Distant metastasis free survival

  5 years

• Disease free survival

  5 years

Other Outcomes (1)

• tumour saftey

  1 week

Study Arms (2)

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Underwent surgical treatment at Peking University People's Hospital, with hospitalization records;
• Preoperative core needle biopsy confirmed breast cancer;
• 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;
• \) 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Central Study Contacts

yuan peng, doctor

CONTACT

86+13671287670; 13671287670@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of breast center

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: January 3, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

CN (1)