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

April 23, 2023 updated by: KUO, WEN-LING, Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Memeorial Hospital, Linkou Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

    1. Meet at least one of the following indications of NSM for breast cancer:

      1. 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
      2. Breast cancer up to stage IIIa (T3, N1-2) as the initial clinical stage showing adequate response to neoadjuvant therapy and meet criteria a.
      3. 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
    2. Age equal to or above 20 years
    3. ECOG (Eastern Cooperative Oncology Group) performance score 0-1
    4. ASA anesthesia risk class 1~2, and with adequate organ functions
    5. Understanding of the method, benefit and risk and willing to receive immediate breast reconstruction

Exclusion Criteria:

  1. 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
  2. Stage III (up to T3, N1-2) breast cancer without response to neoadjuvant treatment
  3. Previous radiotherapy on the surgical site of breast
  4. Patients with severe systemic disease reaching ASA (American Society of Anesthesiologists) physical status classification equal or greater than 3
  5. Patients with bleeding disorder or coagulopathy
  6. Patients with BMI 35.0 or higher
  7. Patients with habitual smoking
  8. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical performance
Time Frame: 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
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Acute Complications
Time Frame: 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
Day 1-Day 30
Incidence of Treatment-Emergent Mortality and Morbidity
Time Frame: Day 1-Day 30
Morbidity and mortality rate resulting from surgery among per protocol population
Day 1-Day 30

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: Day 1
Blood loss in milliliters resulting from SP robotic mastectomy, and breast reconstruction respectively
Day 1
Surgical time
Time Frame: 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
Day 1
Body mass index
Time Frame: Day 0-1
Patient weight and height to report BMI in kg/m^2
Day 0-1
Specimen weight
Time Frame: Day 1
Mastectomy specimen weight in miligrams
Day 1
Mastectomy incision
Time Frame: Day 1
Location and length in centimeters of robotic mastectomy incision
Day 1
Oncological safety
Time Frame: 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)
Day 1-Day 30
Reconstructive surgery
Time Frame: 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
Day 1-Day 2
Drain output
Time Frame: Day 2-15
Daily drain output in milliliters
Day 2-15
Duration of admission
Time Frame: Day 0-60
Total duration of admission in days for robotic mastectomy and immediate breast reconstruction
Day 0-60
Long term complications
Time Frame: Day 90~
Rate of complications resulting from robotic mastectomy and concomitant reconstruction more than 3 months after surgery
Day 90~
Patient-reported esthetic outcome
Time Frame: Day0, Day30, Day90, Day180, and Day360
Serially evaluated patient-reported scores from Breast Q questionnaire
Day0, Day30, Day90, Day180, and Day360
Patient-reported quality of life outcome for breast cancer cases
Time Frame: 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.
Day0, Day30, Day90, Day180, and Day360
Patient-reported breast-specific quality of life outcome for breast cancer cases
Time Frame: 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.
Day0, Day30, Day90, Day180, and Day360
Postoperative pain
Time Frame: 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)).
Day2, Day4, Day6, Day8, Day15
Physician-evaluated outcomes
Time Frame: 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.
Picture taken on Day0, Day30, Day90, Day180, and Day360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Intuitive Surgical

Investigators

  • Principal Investigator: Wen-Ling Kuo, MD. PhD., Breast Cancer Center, Chang Gone Memorial Hospital , Linkou Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

June 18, 2022

First Submitted That Met QC Criteria

July 2, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202101421A0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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