Pilot Study of Single-port Robot-assisted Nipple-sparing Mastectomy

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05448963

Collaborator

Intuitive Surgical (Industry)

Enrollment

Location

Arm

12.1

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Nipple-sparing mastectomy (NSM) is indicated for breast cancer requiring total mastectomy and without nipple involvement by cancer. Robot-assisted mastectomy enables removal of the whole breast tissue with well-preserved breast skin envelope through a single longitudinal incision in the anterior axillary line at the nipple areolar level. The next-generation robot, da Vinci SP system, is single-armed, equipped with multiple flexible instruments and camera, which is likely to improve the efficacy of robotic mastectomy. The investigator's scope of this study is to establish the feasibility and safety of SP-applied NSM through this single-armed pilot trial. Participants with breast cancer indicated for nipple-sparing mastectomy or candidates of prophylactic mastectomy carrying germline pathogenic or likely pathogenic BRCA1/2 mutations are recruited to receive SP-assisted unilateral or bilateral NSMs. Immediate breast reconstruction is followed according to the mode of the plastic surgeon's clinical decision. The primary endpoint is technical feasibility, and the secondary endpoint is safety and patient-reported outcome.

Condition or Disease	Intervention/Treatment	Phase
Nipple-sparing Mastectomy Prophylactic Mastectomy Breast Cancer BRCA1 Mutation BRCA2 Mutation	Device: da Vinci SPⓇ Single-port System	N/A

Detailed Description

About 49% of breast cancer surgery is managed by total mastectomy, and half of the patients undergo breast reconstruction. Nipple-sparing mastectomy (NSM) is indicated for breast cancer requiring total mastectomy and without nipple involvement by cancer. The local recurrence rate is not increased and the cosmetic result much improved. Robot-assisted mastectomy utilizes surgeon-controlled robotic arms with delicate, multi-jointed instruments and 3-dimentional high-definition camera in place of conventional instruments under bare eye vision. Through a single longitudinal incision in the anterior axillary line at the nipple areolar level, the lesion and the whole breast tissue can be totally removed with negative resection margins and well-preserved breast skin envelope. Breast reconstruction can be successfully performed through the same incision and results in a scarless front view. Currently, this surgery is effectively carried out with da Vinci Xi system. However, the small incision may result in the collision of robotic arms outside the torso and hence decreases the range of instrument motion. The next-generation robot, da Vinci SP system, is single-armed, equipped with multiple flexible instruments and camera, which are devoid of outside collision and allows work in a larger surgical field through the same small incision. The SP system reduces blind areas in the surgical field and the blockade of camera vision by the detached space-taking specimens, and, therefore, will hopefully reduce the surgical time. The investigator's scope of this study is to establish the feasibility and safety of SP-applied NSM through this single-armed pilot trial. The investigators recruit breast cancer women indicated for nipple-sparing mastectomy or candidates of prophylactic mastectomy carrying germline pathogenic or likely pathogenic BRCA1/2 mutations to receive SP-assisted unilateral or bilateral NSMs. Immediate breast reconstruction is followed according to the mode of the plastic surgeon's clinical decision. The primary endpoint is technical feasibility (conversion rate, surgical time), and the secondary endpoint is safety and patient-reported outcome.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

single arm surgical interventionsingle arm surgical intervention

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot Study of Robot-assisted Nipple-sparing Mastectomy Followed by Immediate Breast Reconstruction Using da Vinci SP ® Single-port System

Actual Study Start Date :

Jul 30, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robotic mastectomy Patients receive unilateral or bilateral robot-assisted nipple-sparing mastectomy with or without axillary lymph node dissection	Device: da Vinci SPⓇ Single-port System Nipple-sparing mastectomy with or without axillary lymph node dissection using da Vinci SP single-port system

Arm

Intervention/Treatment

Experimental: Robotic mastectomy

Patients receive unilateral or bilateral robot-assisted nipple-sparing mastectomy with or without axillary lymph node dissection

Device: da Vinci SPⓇ Single-port System

Nipple-sparing mastectomy with or without axillary lymph node dissection using da Vinci SP single-port system

Outcome Measures

Primary Outcome Measures

Surgical performance [Day 1]
Ability in percentage to complete nipple-sparing mastectomy with da Vinci SP system (no conversion to conventional laparoscopic, multiport da Vinci surgery or open surgery; addition of access port to complete the procedure would not be considered as conversion) in per protocol population

Secondary Outcome Measures

Incidence of Treatment-Emergent Acute Complications [Day 1-Day 30]
Rate of incidence of surgery-related acute complications including hemorrhage, infection, skin ischemia, nipple ischemia, flap ischemia, and requirement for debridement or re-operation within 30 days
Incidence of Treatment-Emergent Mortality and Morbidity [Day 1-Day 30]
Morbidity and mortality rate resulting from surgery among per protocol population

Other Outcome Measures

Blood loss [Day 1]
Blood loss in milliliters resulting from SP robotic mastectomy, and breast reconstruction respectively
Surgical time [Day 1]
Time in minutes consumed by robotic mastectomy and robotic operation: total surgical time, docking time, console operation time, mastectomy time, lymph node dissection time, reconstruction time
Body mass index [Day 0-1]
Patient weight and height to report BMI in kg/m^2
Specimen weight [Day 1]
Mastectomy specimen weight in miligrams
Mastectomy incision [Day 1]
Location and length in centimeters of robotic mastectomy incision
Oncological safety [Day 1-Day 30]
The ability to achieve margin-free resection for cancer cases: 1) Resection margin positive rate, 2) Nipple margin positive rate, 3)Nipple areolar complex excision rate (pre-planned, or based on nipple margin status, 4)Axillary surgery type (sentinel lymph node biopsy or axillary lymph node dissection)
Reconstructive surgery [Day 1-Day 2]
Type and status of concomitant breast reconstruction: 1) Type of reconstructive surgery (implant or autologous) 2) Impact reconstruction (if applicable): implant location, implant size/shape, brand/surface texture, or tissue expander location 3) Autologous reconstruction (if applicable): type of autologous tissue used, microsurgery detail, nipple neurotization detail
Drain output [Day 2-15]
Daily drain output in milliliters
Duration of admission [Day 0-60]
Total duration of admission in days for robotic mastectomy and immediate breast reconstruction
Long term complications [Day 90~]
Rate of complications resulting from robotic mastectomy and concomitant reconstruction more than 3 months after surgery
Patient-reported esthetic outcome [Day0, Day30, Day90, Day180, and Day360]
Serially evaluated patient-reported scores from Breast Q questionnaire
Patient-reported quality of life outcome for breast cancer cases [Day0, Day30, Day90, Day180, and Day360]
Serially evaluated patient-reported scores from EORTC-QLQ-C30 including functional and symptomatic scales comprising 30 items. The raw scores are linearly converted to a 0-100 scale, where higher function scores reﬂect more interfered function and higher symptom scores present a higher level of symptoms.
Patient-reported breast-specific quality of life outcome for breast cancer cases [Day0, Day30, Day90, Day180, and Day360]
Serially evaluated patient-reported scores from EORTC-QLQ-B23 including functional and symptomatic scales comprising 23 items. The raw scores are linearly converted to a 0-100 scale, where higher function scores reﬂect more interfered function and higher symptom scores present a higher level of symptoms.
Postoperative pain [Day2, Day4, Day6, Day8, Day15]
Serially evaluated intensity of pain by Numerical Rating Scale (Visual Analog Score) for pain, with scales ranging from 0-10. The intensity of pain increases with higher numerical scores (eg.,no pain(0), moderate pain (5), worst pain (10)).
Physician-evaluated outcomes [Picture taken on Day0, Day30, Day90, Day180, and Day360]
Questionnaires about post-reconstructive breast cosmesis evaluated by independent plastic surgeon through a Likert 5-point scale after reviewing pre-and post-operative pictures, where higher scale indicating higher cosmetic satisfaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women with unilateral or bilateral breast cancer, including invasive and noninvasive carcinoma, eligible for unilateral or bilateral nipple-sparing mastectomy (NSM), either for therapeutic or prophylactic purpose, followed by immediate breast reconstruction.

Meet at least one of the following indications of NSM for breast cancer:
Preoperative clinical tumor sizes less than 5 cm, with adequate tumor-skin distance of at least 3mm and above, and without nipple-areolar involvement in at least 1cm around the nipple by image
Breast cancer up to stage IIIa (T3, N1-2) as the initial clinical stage showing adequate response to neoadjuvant therapy and meet criteria a.
Germline pathogenic/likely pathogenic BRCA1 or 2 mutation carriers (actionable mutations including pathogenic and likely pathogenic mutations) with breast cancer diagnosis or requiring unilateral or bilateral prophylactic mastectomy as a risk reduction procedure
Age equal to or above 20 years
ECOG (Eastern Cooperative Oncology Group) performance score 0-1
ASA anesthesia risk class 1~2, and with adequate organ functions
Understanding of the method, benefit and risk and willing to receive immediate breast reconstruction

Exclusion Criteria:

Extensive breast skin or nipple involvement by cancer including 1) Paget's disease, 2) nipple discharge associated with malignancy, 3) image findings suggesting involvement of the nipple and subareolar tissues 4) inflammatory breast cancer or skin ulceration caused by cancer invasion
Stage III (up to T3, N1-2) breast cancer without response to neoadjuvant treatment
Previous radiotherapy on the surgical site of breast
Patients with severe systemic disease reaching ASA (American Society of Anesthesiologists) physical status classification equal or greater than 3
Patients with bleeding disorder or coagulopathy
Patients with BMI 35.0 or higher
Patients with habitual smoking
Pregnancy