Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy for Breast Cancer

Last updated: July 15, 2020
Sponsor: Changhua Christian Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04049305
CCH-IRB-190414-R
MOST 108-2314-B-371-006-
  • Ages 20-80
  • Female

Study Summary

This study will retrospectively collect and evaluate the surgical outcomes of robotic nipple sparing mastectomy (R-NSM) compared with endoscopic assisted NSM (E-NSM) or conventional NSM (C-NSM) in the management of breast cancer. Multi-centers pooled data analysis would be performed for comparisons of R-NSM compared with C-NSM or E-NSM.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A. Indications and selection criteria for nipple sparing mastectomy (NSM) in generaland conventional nipple sparing mastectomy (C-NSM).

  • NSM will be offered to patients who are suitable for mastectomy but keen toconserve nipple areolar complex (NAC), with or without reconstruction. Patientsmust not have clinical or radiological involvement of the NAC. Patients withnipple involvement proven via intra-operative frozen section analysis willreceive NAC excision and hence a skin-sparing mastectomy (SSM) performed instead.B. Indications and selection criteria for robotic nipple sparing mastectomy (R-NSM) or endoscopic nipple sparing mastectomy (E-NSM)

  • The general inclusion criteria or pre-requisite for nipple sparing mastectomyapply to R-NSM or E-NSM as well.

  • In addition, R-NSM or E-NSM should only include early stage breast cancer (carcinoma in situ, stage I - III A), a tumor size less than 5 cm, no evidence ofmultiple lymph node metastasis, and no evidence of nipple, skin or chest wallinvasion.

Exclusion

Exclusion Criteria:

  • Contraindications for R-NSM, C-NSM or E-NSM include those with apparent NACinvolvement, inflammatory breast cancer, breast cancer with chest wall or skininvasion, locally advanced breast cancer, breast cancer with extensive axillary lymphnode metastasis (stage III B or later), and patients with severe co-morbid conditions,such as heart disease, renal failure, liver dysfunction, and poor performance statusas assessed by the primary physicians.

  • Relative contraindications include women with large (breast cup size larger thanE or breast mastectomy weight >600gm) or ptotic breast as the aesthetic outcomesmay be sub-optimal.

Study Design

Total Participants: 900
Study Start date:
August 22, 2019
Estimated Completion Date:
December 31, 2021

Study Description

Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy, was increasingly performed in breast cancer patients due to better cosmetic outcome, higher patient satisfaction, and maintained oncologic safety. Minimal invasive surgery had become the main stream of operations, and new surgical innovations of NSM, like endoscopic nipple sparing mastectomy (E-NSM) or robotic nipple sparing mastectomy (R-NSM), were emerging and applied in the surgical treatment of breast cancer. E-NSM, which is performed through small axillary and/or peri-areolar incisions, was reported to be associated with small inconspicuous incision and good cosmetic outcome. Conventional E-NSM was performed with two separate incisions over axilla and peri-areolar regions. E-NSM with areolar incision, just like NSM with areolar related incision (NAC ischemia/necrosis rate: range 7%-81.8%), was associated with increased NAC ischemia/necrosis (reported ranged: 9.1-19%). New technique modifications of E-NSM were emerging focusing on single axillary incision NSM, which spare the peri-areolar incision and thereby decrease the compromise of bloody supply from mastectomy skin flap, was reported to have low NAC necrosis rate (0%). However, the 2-dimensional endoscopic in-line camera produces an inconsistent optical window around the curvature of the breast skin flap, and the internal mobility was limited and the dissection angles were inadequate with traditional endoscopic rigid tips instruments through single access. Due to the limitations of endoscopy instruments and technique difficulty, neither conventional E-NSM nor single access E-NSM was widespread used in breast cancer R-NSM, which introduce da Vinci surgical platform through a small extramammary axillary or lateral chest wound to perform NSM, had been applied in the surgical treatment of early breast cancer or risk reducing mastectomy. R-NSM, which incorporated 3- dimensional (3D) imaging system and flexibility of robotic arm and instruments, was reported to have the potential to overcome the technique difficulty of E-NSM. The preliminary results of R-NSM from current literature reported series and ours were safe, and associated with good cosmetic outcome and high patients' satisfaction. However, evidence comparing R-NSM to conventional NSM (CNSM) or E-NSM was lacking. In this study, the authors aim to investigate and analyze the clinical and aesthetic outcomes as well as the cost effectiveness of R-NSM through a longitudinal cohort study design whereby a retrospective review will be carried out for patients undergoing R-NSM, E-NSM or C-NSM. Multi-centers pooled data analysis would be performed for comparisons of R-NSM compared with C-NSM or E-NSM.

Connect with a study center

  • European Institute of Oncology

    Milan,
    Italy

    Site Not Available

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Changhua Christian Hospital

    Changhua,
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung,
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    Taichung,
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • Taipei Municipal Wan Fang Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • Shuang-Ho Hospital - Taipei Medical University

    Taipei county,
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital

    Taoyuan,
    Taiwan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.