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

NCT04037852 | Unknown DMC FDA Device

• 2 other identifiers: CCH-IRB-190414-P108-2314-B-371-006-
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Breast Cancer Female

Keywords

nipple sparing mastectomy; robotic nipple sparing mastectomy (R-NSM); conventional nipple sparing mastectomy (C-NSM); endoscopic assisted nipple sparing mastectomy (E-NSM); immediate breast reconstruction (IBR); immediate prothesis breast reconstruction (IPBR)

Outcome Measures

Primary Outcomes (10)

• Operation time

  Overall operation time (minute), including breast cancer operations, lymph node surgery, and breast reconstructions

  immediate post operation

• Morbidity and complications

  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

  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

  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

  \- 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

  Blood loss (ml) from skin incision to completion of operations

  immediate post operation

• Hospital stay

  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

  Mean mastectomy weight (gm) of patients received different mastectomy operations

  immediate post operation

• Reconstruction implant volume

  Reconstruction implant volume (ml)

  immediate post operation

• Pain assessments

  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 Outcomes (3)

• Cost- analysis of C-NSM versus R-NSM or E-NSM

  post operation one month

• Disease free survival

  5 years post operation

• Overall Survival

  5 years post operation

Study Arms (3)

Robotic assisted nipple sparing mastectomy (R-NSM)

EXPERIMENTAL

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

Conventional nipple sparing mastectomy (C-NSM)

ACTIVE COMPARATOR

Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy.

Procedure: Conventional nipple sparing mastectomy

Endoscopic assisted nipple sparing mastectomy (E-NSM)

ACTIVE COMPARATOR

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

Interventions

robotic assisted nipple sparing mastectomy DEVICE

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.

Robotic assisted nipple sparing mastectomy (R-NSM)

Endoscopic assisted nipple sparing mastectomy PROCEDURE

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%).

Endoscopic assisted nipple sparing mastectomy (E-NSM)

Conventional nipple sparing mastectomy PROCEDURE

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.

Conventional nipple sparing mastectomy (C-NSM)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Changhua Christian Hospital: lead
• Intuitive Surgical: collaborator
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (11)

Changhua Christian Hospital

Changhua, 500, Taiwan

RECRUITING

Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

Kaohsiung City, Taiwan

RECRUITING

China Medical University Hospital, Taichung, Taiwan

Taichung, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

RECRUITING

Shuang-Ho Hospital - Taipei Medical University

Taipei, Taiwan

RECRUITING

Taipei Municipal Wan Fang Hospital, Tawian

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

Chang Gung Memorial Hospital, Taoyuan, Taiwan

Taoyuan District, Taiwan

RECRUITING

Related Publications (15)

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  PMID: 28692558 BACKGROUND

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  PMID: 37226826 DERIVED

Study Officials

• Hung-Wen Lai, MD, PhD

  Changhua Christian Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Wen Lai, MD, PhD

CONTACT

+886933496822; hwlai650420@yahoo.com.tw

Shu-Hsin Pai, MS

CONTACT

69584@cch.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: prospective, non-randomized, non-masking, open label, 3 arms
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective registry of R-NSM versus C-NSM or E-NSM in the management of breast cancer. 3 arms study for comparisons

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 30, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: February 28, 2022
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (11)