Trial Title:
Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction
NCT ID:
NCT05490433
Condition:
Breast Cancer Patients in Stage 0-3A in Preoperative Evaluation
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
RNSM and CNSM procedures are systematic at 1:1 ratio after obtaining consent forms for
research participation and checking criteria for exclusion from selection It is randomly
assigned from the award. The patient is subjected to a single blind examination so that
the surgical method is unknown before surgery.
Reconstruction methods after resection are discussed with breast and/or plastic surgeons
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
robot assisted nipple sparing mastectomy(RNSM)
Description:
Patients receiving RNSM and IBR are enrolled in this group. The RNSM is performed using a
robotic surgical system.
The robotic surgical system includes da Vinci S, Si, X, Xi, and SP Systems. An armpit or
lateral chest incision is used in this surgical procedure. A lateral chest incision is
used. Posterior flow tissue collection is recommended for frozen segment biopsy during
surgery. If a suspected lesion is observed on the superficial or posterior interface
during surgery, a frozen section for that lesion. Biopsy is recommended. For NAC,
superficial edges, and/or posterior edges in frozen intercept biopsy, If tumor invasion
is identified, additional resection or postoperative radiotherapy, including skin and
NAC, should be considered do. In IBR, tissue extensor insertion, prosthesis insertion,
photolateral sheath, transverse abdominal rectangular sheath, or deep lower abdominal
perforated vessels. The skin plate is applicable.
Arm group label:
robot assisted nipple sparing mastectomy(RNSM)
Intervention type:
Procedure
Intervention name:
Conventional nipple sparing mastectomy(CNSM)
Description:
Patients who receive CNSM and IBR are enrolled in this group. CNSM uses a robot or
endoscopic surgical system Do not travel. All kinds of skin incisions can be performed in
this technique. It is recommended to collect posterior mammary gland tissue for frozen
segment biopsy during surgery. If a lesion suspected of tumor invasion is observed at the
edge of the surface or posterior edge during surgery, a freeze-intercept biopsy is
recommended for that lesion.
If a frozen segment biopsy identifies invasion of tumors on NAC, superficial edges,
and/or posterior edges, further resection or postoperative radiotherapy, including skin
and NAC, is considered.
In IBR, tissue extensor insertion, prosthesis insertion, photomultiplier sheath,
transverse rectangular sheath, or deep lower abdominal perforated vessels.
It includes a sheath. It is excluded if there is no IBR.
Arm group label:
Conventional nipple sparing mastectomy(CNSM)
Summary:
the purpose of the study: It provides the highest level of evidence ever studied on the
use of robotic surgical systems during breast surgery for breast cancer treatment, and
aims to reveal the clinical significance of successive breast reconstruction(immediate
breast reconstruction, IBR) at the same time as Robot-assisted nipple-sparing mastectomy
(RNSM)
Detailed description:
- Background: Robot-assisted nipple-sparing mastectomy (RNSM) has emerged for breast
cancer treatment and for risk reducing mastectomy in women who have high risk of
pathogenic variants. Even though several studies have reported that RNSM is a
feasible procedure, some argue that RNSM is only performed by several specialized
surgeons and there is only limited data reporting about the oncologic outcomes and
patient reported outcomes (PRO). Recently, the United States Food and Drug
Administration and several surgeons have warned that robot breast surgery should be
performed only by specialized surgeons and the benefits, risks, and alternatives of
all available treatment options should be discussed with patients to make the most
informed treatment decision. The Korea Robot-Endoscopy Minimal Access Breast Surgery
Study Group (KoREa-BSG) has been established to evaluate, standardize, and teach
this cutting-edge procedure. We designed a prospective multicenter randomized
clinical trial evaluating oncologic outcomes of RNSM with immediate breast
reconstruction (IBR) compared to open conventional NSM (CNSM) with IBR, which is
Robot vs. Open nipple-sparing Mastectomy trial (ROM trial).
- Detail description: This study is a multi-organ randomized clinical trial that
evaluates oncological results of RNSM compared to Conventional Nipple Sparing
Mastectomy (CNSM).
Retrospective studies on robot-endoscopic surgery have shown that beginners are
technically feasible and reliable with a short learning curve.
However, the absence of a well-organized randomized trial remains a major limitation in
expanding robotic surgery in breast surgery worldwide, so in this study, we designed a
prospective multi-organ randomized trial 'Robot-to-Open Nipple Preservation Mastectomy
Clinical Trial' compared to CNSM for oncological results after RNSM and IBR.
- Data collection: Collections of clinical pathological factors include height,
weight, breast volume/weight, age, germline likely pathogenic/pathogenic mutation,
affected breast, bilateral surgery, breast ptosis, Tumor size, TNM stage,
histological grade, histological type, estrogen receptor (ER), progesterone receptor
(PR), human epidermal growth factor (HER), Ki67 levels, nipple invasion status,
adjuvant/neoplastic treatment status, and postoperative complications by
clavien-Dindo classification, surgical time, border invasion, postoperative
drainage/period, RRM performance, reconstruction type, patient's pre-surgical
recurrence status, medical cost data, and follow-up data.
- Subject satisfaction assessment: After 3 to 12 months (+-30 days) of final surgery,
the subject was surveyed to evaluate satisfaction with robotic surgery. Follow the
BREAST-Q Korean questionnaire for evaluation.
- Cost effectiveness evaluation according to surgical method (option): The cost
effectiveness of robotic surgery is evaluated by surveying the subject 3 to 12
months after the final surgery (+-30 days). Follow the EQ5D Korean.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult women over the age of 19 with breast cancer scheduled for therapeutic
mastectomy and who want immediate reconstruction
- Stage 0-III breast cancer at initial evaluations
- ECOG performance status of 0 or 1
Exclusion Criteria:
- Patients planned for breast-conserving surgery or who are not candidates for IBR are
excluded.
- Clinical evidence for nipple or skin involvement of tumors in preoperative
evaluations
- A pregnant or lactating woman
- Only tumors with lobular carcinoma in situ
- Mammary Paget's disease
- Inflammatory breast cancer
- Male breast cancer
- Stage IIIB-IV disease at initial presentation
- Women with breast Cup E or higher
- Previous history of breast cancer (metachronous breast cancer)
- Previous history of non-mammary malignant disease excluding non-melanoma skin cancer
or thyroid papillary/follicular cancer
- Special type cancer (phyllodes tumor, sarcoma, and lymphoma)
- Age > 70
- ASA, grade 4 or higher
- Patients who do not have the ability to give informed consent
- Previous thoracic radiation history
- Patients who have not been tested for hepatitis before surgery (HBV, HCV) and HIV
(compensation insurance policy)
Gender:
Female
Gender based:
Yes
Minimum age:
19 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Changwon Medical Center
Address:
City:
Changwon
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Hee Jun Choi, M.D. PhD
Phone:
82-10-9955-5801
Email:
heejun1.choi@samsung.com
Facility:
Name:
Keimyung University Dongsan Hospital
Address:
City:
Daegu
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Moo Hyun Lee, MD
Phone:
010-2315-0197
Email:
mhlee197@gmail.com
Facility:
Name:
Kyungpook National University Chilgok Hospital
Address:
City:
Daegu
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Jeeyeon Lee, MD, PhD
Phone:
82-10-5134-0001
Email:
j.lee@knu.ac.kr
Facility:
Name:
Myongji Hospital
Address:
City:
Goyang-si
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Hyukjai Shin, M.D. PhD
Phone:
82 10 8803 5433
Email:
drgsshj@gmail.com
Facility:
Name:
The Catholic University of Korea, Incheon ST. Mary's Hospital
Address:
City:
Incheon
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Young Joon Kang, M.D. PhD.
Phone:
010-2638-3847
Email:
yjkang.md@gmail.com
Facility:
Name:
Kosin University Gospel Hospital
Address:
City:
Pusan
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Ku Sang Kim, v
Phone:
82-10-4551-2171
Email:
ideakims@gmail.com
Facility:
Name:
Chungnam National University Sejong Hospital
Address:
City:
Sejong
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Younju Lee
Phone:
82-10-3356-4405
Email:
jaennejuya@cnuh.co.kr
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Sae Byeol Lee, MD, PhD
Phone:
82-10-7209-4620
Email:
newstar153@hanmail.net
Facility:
Name:
Gangnam Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Sung Gwe Ahn, M.D, Ph.D
Phone:
82-10-9948-0247
Email:
ASG2004@yuhs.ac
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Ji Young You, MD, PhD
Phone:
82-10-3554-7482
Email:
mdjean83@gmail.com
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Jai Min Ryu, MD, PhD
Phone:
82-10-9933-5243
Email:
sheol1981@naver.com
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Han-Byoel Lee, MD, PhD
Phone:
82-10-9035-8211
Email:
hblee80@gmail.com
Facility:
Name:
Yonsei University Health System, Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyung Seok Park, MD, PhD
Phone:
82-10-6760-2974
Email:
imgenius@yuhs.ac
Facility:
Name:
Yongin Severance Hospital
Address:
City:
Yongin-si
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Joo Heung Kim, M.D.
Phone:
82-10-7203-1555
Email:
PIANAC@yuhs.ac
Start date:
October 26, 2022
Completion date:
June 2030
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05490433
