Back to resultsPilot Study of Single-port Robot-assisted Nipple-sparing Mastectomy
Primary Purpose
Nipple-sparing Mastectomy, Prophylactic Mastectomy, Breast Cancer
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
da Vinci SPⓇ Single-port System
Sponsored by
About this trial
This is an interventional treatment trial for Nipple-sparing Mastectomy focused on measuring robotic mastectomy, robot-assisted mastectomy, nipple-sparing mastectomy, axillary lymph node dissection, breast cancer surgery, breast reconstruction, prophylactic mastectomy, single-port systems
Eligibility Criteria
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
Sites / Locations
- Chang Gung Memeorial Hospital, Linkou Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robotic mastectomy
Arm Description
Patients receive unilateral or bilateral robot-assisted nipple-sparing mastectomy with or without axillary lymph node dissection
Outcomes
Primary Outcome Measures
Surgical performance
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
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
Morbidity and mortality rate resulting from surgery among per protocol population
Full Information
NCT ID
NCT05448963
First Posted
June 18, 2022
Last Updated
April 23, 2023
Sponsor
Chang Gung Memorial Hospital
Collaborators
Intuitive Surgical
1. Study Identification
Unique Protocol Identification Number
NCT05448963
Brief Title
Pilot Study of Single-port Robot-assisted Nipple-sparing Mastectomy
Official Title
A Pilot Study of Robot-assisted Nipple-sparing Mastectomy Followed by Immediate Breast Reconstruction Using da Vinci SP ® Single-port System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Intuitive Surgical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nipple-sparing Mastectomy, Prophylactic Mastectomy, Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
Keywords
robotic mastectomy, robot-assisted mastectomy, nipple-sparing mastectomy, axillary lymph node dissection, breast cancer surgery, breast reconstruction, prophylactic mastectomy, single-port systems
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single arm surgical intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robotic mastectomy
Arm Type
Experimental
Arm Description
Patients receive unilateral or bilateral robot-assisted nipple-sparing mastectomy with or without axillary lymph node dissection
Intervention Type
Device
Intervention Name(s)
da Vinci SPⓇ Single-port System
Intervention Description
Nipple-sparing mastectomy with or without axillary lymph node dissection using da Vinci SP single-port system
Primary Outcome Measure Information:
Title
Surgical performance
Description
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
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Acute Complications
Description
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
Time Frame
Day 1-Day 30
Title
Incidence of Treatment-Emergent Mortality and Morbidity
Description
Morbidity and mortality rate resulting from surgery among per protocol population
Time Frame
Day 1-Day 30
Other Pre-specified Outcome Measures:
Title
Blood loss
Description
Blood loss in milliliters resulting from SP robotic mastectomy, and breast reconstruction respectively
Time Frame
Day 1
Title
Surgical time
Description
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
Time Frame
Day 1
Title
Body mass index
Description
Patient weight and height to report BMI in kg/m^2
Time Frame
Day 0-1
Title
Specimen weight
Description
Mastectomy specimen weight in miligrams
Time Frame
Day 1
Title
Mastectomy incision
Description
Location and length in centimeters of robotic mastectomy incision
Time Frame
Day 1
Title
Oncological safety
Description
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)
Time Frame
Day 1-Day 30
Title
Reconstructive surgery
Description
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
Time Frame
Day 1-Day 2
Title
Drain output
Description
Daily drain output in milliliters
Time Frame
Day 2-15
Title
Duration of admission
Description
Total duration of admission in days for robotic mastectomy and immediate breast reconstruction
Time Frame
Day 0-60
Title
Long term complications
Description
Rate of complications resulting from robotic mastectomy and concomitant reconstruction more than 3 months after surgery
Time Frame
Day 90~
Title
Patient-reported esthetic outcome
Description
Serially evaluated patient-reported scores from Breast Q questionnaire
Time Frame
Day0, Day30, Day90, Day180, and Day360
Title
Patient-reported quality of life outcome for breast cancer cases
Description
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.
Time Frame
Day0, Day30, Day90, Day180, and Day360
Title
Patient-reported breast-specific quality of life outcome for breast cancer cases
Description
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.
Time Frame
Day0, Day30, Day90, Day180, and Day360
Title
Postoperative pain
Description
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)).
Time Frame
Day2, Day4, Day6, Day8, Day15
Title
Physician-evaluated outcomes
Description
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.
Time Frame
Picture taken on Day0, Day30, Day90, Day180, and Day360
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Ling Kuo, MD. PhD.
Organizational Affiliation
Breast Cancer Center, Chang Gone Memorial Hospital , Linkou Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memeorial Hospital, Linkou Medical Center
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD are to be shared upon request to the principle investigator. The content of data sharing depend on research relevance and cooperative detail.
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Pilot Study of Single-port Robot-assisted Nipple-sparing Mastectomy
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