Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Breast Cancer
- 发起方
- Deborah Farr, MD
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of perioperative complications
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
This is a single arm, single-center, prospective clinical trial designed to track the peri, post-operative and oncologic outcomes when utilizing the da-Vinci single port (SP) robotic platform to perform robotic nipple sparing mastectomy (rNSM) and immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (ADM - Alloderm), for patients with breast cancer as well as those with a high risk for breast cancer.
Safety and feasibility measures will be measured as primary outcome measures. Oncological and patient satisfaction outcome measures will be measured. Our hypothesis is that SPr-NSM is equal to open NSM in terms of safety, feasibility and oncological outcomes with improved patient satisfaction as measured by nipple sensation and patient reported outcomes.
详细描述
rNSM using the multi-port robotic platform followed by standard of care open breast reconstruction has been done successfully at multiple institutions worldwide with comparable, if not superior outcomes to an open surgical approach. This study explores this procedure with the Da Vinci SP robot with pre-pectoral reconstruction with acellular dermal matrix. The patients will be evaluated per standard of care post-operative visits at 2 weeks, 1 month, and every 6 months for five years post operatively for subjective patient satisfaction and objectively for post-operative nipple sensation. The patients will be monitored longitudinally for oncologic outcomes including the presence of a new breast cancer and/or breast cancer recurrence. Patients will be monitored for any complications related to rNSM and the use of ADM in expander and implant-based breast reconstruction. Investigational Device: The da Vinci SP Surgical System, Model SP1098 is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery. The Model SP1098 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument, EndoWrist SP Instruments, and Accessories. Indications for Use: The da Vinci SP Surgical System, Model SP1098 is cleared for use in urologic surgical procedures that are appropriate for a single-port approach and transoral otolaryngology procedures restricted to T1 and T2 tumors. This investigational study will evaluate device usage in nipple sparing mastectomy (NSM) procedures.
研究者
Deborah Farr, MD
ASSOC PROFESSOR
University of Texas Southwestern Medical Center
入排标准
入选标准
- •Candidates for open nipple sparing mastectomy, per standard of care with regards to anatomic factors and tumor location including: nipple sparing resection and resection OR prophylactic mastectomy for risk reduction OR treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Inability to provide informed consent
- •Pregnant or nursing women
- •Patients with:
- •Inflammatory breast cancer
- •Skin involvement with tumor
- •Pre-operative diagnosis of Nipple Areolar Complex (NAC) tumor involvement
- •Grade 3 or higher nipple ptosis
- •Contraindicated for general anesthesia or surgery
- •Heavy current smoking history (defined as \> 20 cigarettes per day)
结局指标
主要结局
Incidence of perioperative complications
时间窗: 30 days following surgery
Perioperative complications will be described using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v. 4.03 criteria. Complications will refer to any medical occurrence directly attributed to the surgical procedure during and within the first 30 days following use of the SP robotic platform and ADM. Grade 3, 4, or 5 complication or adverse event will constitute an event. Perioperative complication rates will be compared to historical complication rates.
Number of participants who complete single port nipple sparing mastectomy (SPrNSM)
时间窗: Date of surgery (Day 1)
The number of participants who complete single port nipple sparing mastectomy (SPrNSM) will be measured.
次要结局
- Number of participants with positive margins(2 weeks following date of surgery)
- Number of participants with recurrent breast cancers(following date of surgery up to 5 years)
- Number of participants with new breast cancers(following date of surgery up to 5 years)
- Incidence of short term complications(Post-operatively at 30 days)
- Patient satisfaction as measured by BREAST-Q sensation tool(Baseline, postoperatively at 2 weeks, every 6 months for 5 years)
- Degree to which the patients maintain nipple sensation as measured by Semmes Weinstein monofilament tool at baseline(Baseline, postoperatively at 2 weeks, every 6 months for 5 years)
- Patient satisfaction as measured by BREAST-Q reconstruction tool(Baseline, postoperatively at 2 weeks, every 6 months for 5 years)
- Incidence of long term complications(Following surgery up to 5 years)