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NCT Number: NCT06748677

Endoscopic and Robotic NSM with Immediate Prosthesis Breast 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.

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Key information

Conditions

Nipple-sparing Mastectomy Endoscopic Surgery Immediate Prosthesis Reconstruction Robotic Surgery

Sex eligibility

Female

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

yuan peng, doctor

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

Primary outcomes

  1. incidence of postoperative complications

    Time frame: 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 outcomes

  1. Patient-reported Outcome Measures

    Time frame: 1 year

    BREAST-Q scores, higher scores mean a better outcome

  2. local-regional recurrence

    Time frame: 5 years

    From research enrollment to ipsilateral breast skin, subcutaneous, chest wall, axillary, internal mammary, and supraclavicular lymph node recurrence;

  3. Distant metastasis free survival

    Time frame: 5 years

    the time from enrollment in the study to the occurrence of distant recurrence and metastasis;

  4. Disease free survival

    Time frame: 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.

Other outcomes

  1. tumour saftey

    Time frame: 1 week

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

yuan peng, doctor

CONTACT

[email protected]

86+13671287670

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Acronym: EnRoNSM

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Dec 27, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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