About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial 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
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Patient-reported Outcome Measures
BREAST-Q scores, higher scores mean a better outcome
local-regional recurrence
From research enrollment to ipsilateral breast skin, subcutaneous, chest wall, axillary, internal mammary, and supraclavicular lymph node recurrence;
Distant metastasis free survival
the time from enrollment in the study to the occurrence of distant recurrence and metastasis;
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.
Other outcomes
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.
Sponsors and contacts
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