Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy for Breast Cancer

Not Applicable

• Conditions: Breast Cancer Female

• Registration Number: NCT04049305
• Lead Sponsor: Changhua Christian Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-08
• Study Start: 2019-08-22
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-16
• Primary Completion: 2021-07-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

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

  • NSM will be offered to patients who are suitable for mastectomy but keen to conserve nipple areolar complex (NAC), with or without reconstruction. Patients must not have clinical or radiological involvement of the NAC. Patients with nipple involvement proven via intra-operative frozen section analysis will receive 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 mastectomy apply 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 of multiple lymph node metastasis, and no evidence of nipple, skin or chest wall invasion.

Exclusion Criteria

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Operation time	immediate post operation	Overall operation time (minute), from skin incision to completion of operations. Compared overall operation time between R-NSM, C-NSM and E-NSM.
Skin blister formation	within one month (30 days) post operation	rate of skin blister formation between R-NSM, C-NSM and E-NSM groups.
Implant loss rate	within one month (30 days) post operation	rate of implant loss between R-NSM, C-NSM and E-NSM groups.
Rate of Surgical margin involvement in specimen pathologic examination	post operative 2 weeks after pathologic report available	Rate of Surgical margin involvement in specimen during pathologic examination, and surgical margin involvement was defined as tumor on the ink.
Skin flap ischemia/necrosis rate	within one month (30 days) post operation	rate of skin flap ischemia/necrosis between R-NSM, C-NSM and E-NSM groups.
Reconstruction implant volume	immediate post operation	Reconstruction implant volume (ml) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)
Wound healing status	within one month (30 days) post operation	rate of Delayed wound healing between R-NSM, C-NSM and E-NSM groups.
Grade of Nipple areolar complex ischemia/necrosis	evaluated in post operative 2 weeks to 3 months post operation	The perfusion of NAC was evaluated in 2 weeks to 3 months post operation. The survival of NAC was confirmed at post-operative 3 months.; The NAC ischemia/necrosis was divided into 5 different grades, which were: 1. No ischemia/necrosis was observed in NAC (Grade I).; 2. Transient ischemia recovered without necrosis (Grade II).; 3. Partial ischemia/necrosis, recovered without loss of nipple volume (Grade III).; 4. Partial NAC necrosis with partial volume loss of nipple (Grade IV).; 5. Total NAC necrosis with all volume loss of nipple (Grade V). NAC ischemia/necrosis was segregated into no NAC necrosis (Grade I-III) and NAC necrosis (Grade IV-V).; The ischemia/necrosis of NAC between different R-NSM, C-NSM and E-NSM groups were recorded and compared.
Blood loss during operation	immediate post operation	Blood loss (ml) during operation was compared between groups (R-NSM, C-NSM and R-NSM)
Post operation Bleeding/hematoma rate	within one month (30 days) post operation	rate of post operative bleeding/hematoma between R-NSM, C-NSM and E-NSM groups.
Aesthetic outcome evaluation-Patient reported cosmetic outcome results	1-3 months after the operation when the wound was healed	- Post-operative aesthetic results will be evaluated by comparing pre-operative and post-operative results. A selfreported questionnaire to evaluate the cosmetic outcome of breast cancer patients with mastectomy following breast reconstruction was conducted 1-3 months after the operation. This questionnaire comprises of 10 questions based on 4 itemized scales, which will be graded as "1, dis-satisfied", "2, fair", "3, satisfied", and "4, very satisfied".
Mean mastectomy weight	immediate post operation	Mean mastectomy weight (gm) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)
Seroma formation rate	within one month (30 days) post operation	rate of post operative seroma formation needing repeat aspiration between R-NSM, C-NSM and E-NSM groups.
Hospital stay	within 2 weeks of operation	Hospital stay (days) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)

Secondary Outcome Measures

Name	Time	Method
Cost- analysis of C-NSM versus R-NSM or E-NSM	post operation one month	The medical cost associated with robotic versus conventional or endoscopic assisted NSM will be collected and compared. The medical cost incurred for each procedure include overall hospital cost. Information on surgery related expenses will obtained from the finance department of the institution. In Taiwan, the operation fees of breast reconstruction and robotic breast surgery are not reimbursed by national insurance.; The medical cost covered by national insurance include operations fee for breast cancer and/or axillary lymph node surgery, anesthesia, admission fee, and all other medical related expenses.; * The medical cost not reimbursed by national insurance, and needed to be paid for by patients include fees for breast reconstruction, robotic breast surgery, endoscopic breast surgery, instruments and prosthetic implants.; * Cost is expressed in New Taiwan dollars (NTDs) and in United States dollars (USDs). An exchange rate of 31 NTD/USD was used to convert NTD to USD.
Disease free Survival	5 years post operation	disease-free survival between R-NSM, C-NSM or E-NSM .
Overall survival	5 years post operation	overall survival between R-NSM, C-NSM or E-NSM .

Trial Locations

Locations (13)

European Institute of Oncology; 🇮🇹 Milan, Italy

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Shuang-Ho Hospital - Taipei Medical University; 🇨🇳 Taipei county, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan

Taipei Municipal Wan Fang Hospital; 🇨🇳 Taipei, Taiwan

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