Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer-Prospective Study (RCENSM-P)

September 10, 2021 updated by: Changhua Christian Hospital

Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer- A Prospective Registry Case Control Study

This study will prospectively evaluate the surgical outcomes of robotic nipple sparing mastectomy (NSM) compared with endoscopic assisted NSM or conventional NSM in the management of breast cancer. One-third patients would received R-NSM, another one-third received C-NSM while the other one-third would receive E-NSM.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 extra-mammary 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 reported series and ours were safe, and associated with good cosmetic outcome and high patients' satisfaction. However, evidence comparing R-NSM to conventional NSM (C-NSM) 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 prospective cohort of patients undergoing R-NSM, E-NSM or C-NSM.

Study Type

Interventional

Enrollment (Anticipated)

180

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 Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • Changhua Christian Hospital
        • Contact:
        • Principal Investigator:
          • Hung-Wen Lai, MD, PhD
        • Sub-Investigator:
          • Shou-Tung Chen, MD
        • Sub-Investigator:
          • Dar-Ren Chen, MD
      • Kaohsiung, Taiwan
        • Recruiting
        • Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fu Ou-Yang
        • Principal Investigator:
          • Fang-Ming Chen
      • Taichung, Taiwan
        • Recruiting
        • China Medical University Hospital, Taichung, Taiwan
        • Contact:
        • Principal Investigator:
          • Liang-Chih Liu, MD, PhD
      • Tainan, Taiwan
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
        • Principal Investigator:
          • Yao-Lung Kuo, MD, PhD
      • Taipei, Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Chiun-Sheng Huang, MD, PhD
      • Taipei, Taiwan
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
        • Principal Investigator:
          • Guo-Shiou Liao, MD
      • Taipei, Taiwan
        • Recruiting
        • Shin Kong Wu Ho-Su Memorial Hospital
        • Contact:
          • Tsui-Fen Cheng, MD, MPH
          • Phone Number: 2086 +886228332211
          • Email: Sgtw88@gmail.com
        • Principal Investigator:
          • Tsui-Fen Cheng, MD, MPH
      • Taipei, Taiwan
        • Recruiting
        • Shuang-Ho Hospital - Taipei Medical University
        • Contact:
          • Chin-sheng Hung, MD, PhD
          • Phone Number: 8123 +886-2-27372181
          • Email: hungcs@tmu.edu.tw
        • Principal Investigator:
          • Chin-sheng Hung, MD, PhD
      • Taipei, Taiwan
        • Recruiting
        • Taipei Municipal Wan Fang Hospital, Tawian
        • Contact:
        • Principal Investigator:
          • Wei-Wen Chang, MD
      • Taoyuan, Taiwan
        • Recruiting
        • Chang Gung Memorial Hospital, Taoyuan, Taiwan
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wen-Ling Kuo, MD, PhD
        • Sub-Investigator:
          • Hsiu-Pei Tsai, MD

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 - IIIA), 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 suboptimal.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic assisted nipple sparing mastectomy (R-NSM)
R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM.
Device: robotic assisted nipple sparing mastectomy
R-NSM, which introduce da Vinci surgical platform through a small extra-mammary 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.
Active Comparator: Conventional nipple sparing mastectomy (C-NSM)
Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy.
Procedure: Conventional nipple sparing mastectomy
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.
Active Comparator: Endoscopic assisted nipple sparing mastectomy (E-NSM)
E-NSM, which is performed through small axillary and/or peri-areolar incisions, with endoscopic instruments to performed nipple sparing mastectomy.
Procedure: Endoscopic assisted nipple sparing mastectomy
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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: immediate post operation
Overall operation time (minute), including breast cancer operations, lymph node surgery, and breast reconstructions
immediate post operation
Morbidity and complications
Time Frame: within one month (30 days) post operation
Delayed wound healing, degree of nipple ischemia/necrosis, seroma formation needing repeated aspiration, Blister formation, Skin flap ischemia necrosis, Hematoma formation, Implant loss will be collected and analyzed between different R-NSM, C-NSM and E-NSM groups.
within one month (30 days) post operation
Nipple areolar complex ischemia/necrosis grading
Time Frame: evaluated in post operative 2 weeks to 3 months post operation

To evaluate the post-operative perfusion and survival of nipple areolar complex (NAC), a grading system was used in current study.

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.
evaluated in post operative 2 weeks to 3 months post operation
Surgical margin involvement
Time Frame: post operative 2 weeks after pathologic report available
Surgical margin involvement was defined as tumor on the ink. The postoperative adjuvant hormone therapy, chemotherapy and radiotherapy were given to patients according to current breast cancer guidelines.
post operative 2 weeks after pathologic report available
Aesthetic outcome evaluation-Patient reported cosmetic outcome results
Time Frame: 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 self-reported 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".
1-3 months after the operation when the wound was healed
Blood loss during operations
Time Frame: immediate post operation
Blood loss (ml) from skin incision to completion of operations
immediate post operation
Hospital stay
Time Frame: within 2 weeks of operation
Hospital stay (days) during operation period, recorded from admission to day of discharge at the breast cancer operation.
within 2 weeks of operation
Resection mastectomy weight
Time Frame: immediate post operation
Mean mastectomy weight (gm) of patients received different mastectomy operations
immediate post operation
Reconstruction implant volume
Time Frame: immediate post operation
Reconstruction implant volume (ml)
immediate post operation
Pain assessments
Time Frame: within post operation two weeks
Pain assessments will also be collected as part of the post-operative parameters. Visual analogue scale (VAS) for pain assessments will be used in this study (range from 0 to 10 points, 0 indicate no pain, 10 indicate maximal pain ever experienced). VAS for pain per day would be recorded very day and compared.
within post operation two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost- analysis of C-NSM versus R-NSM or E-NSM
Time Frame: 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.
post operation one month
Disease free survival
Time Frame: 5 years post operation
any local regional recurrence, or distant metastasis was recorded as an event. Disease free survival would be compared between R-NSM, C-NSM and E-NSM groups
5 years post operation
Overall Survival
Time Frame: 5 years post operation
overall survival would be compared between R-NSM, C-NSM and E-NSM groups
5 years post operation

Collaborators and Investigators

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

Sponsor

Changhua Christian Hospital

Collaborators

Ministry of Science and Technology, Taiwan
Intuitive Surgical

Investigators

  • Principal Investigator: Hung-Wen Lai, MD, PhD, Changhua Christian Hospital

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)

October 1, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

July 28, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCH-IRB-190414-P
  • 108-2314-B-371-006- (Other Grant/Funding Number: MOST)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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