Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Официальное название

Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство da Vinci SP Surgical System
  This is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery.

Первичные конечные точки

• Number of participants who complete single port nipple sparing mastectomy (SPrNSM) [Срок оценки: Date of surgery (Day 1)]
• Incidence of perioperative complications [Срок оценки: 30 days following surgery]

Вторичные конечные точки (8)

• Number of participants with positive margins [Срок оценки: 2 weeks following date of surgery]
• Number of participants with new breast cancers [Срок оценки: following date of surgery up to 5 years]
• Number of participants with recurrent breast cancers [Срок оценки: following date of surgery up to 5 years]
• Patient satisfaction as measured by BREAST-Q reconstruction tool [Срок оценки: Baseline, postoperatively at 2 weeks, every 6 months for 5 years]
• Patient satisfaction as measured by BREAST-Q sensation tool [Срок оценки: 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 [Срок оценки: Baseline, postoperatively at 2 weeks, every 6 months for 5 years]
• Incidence of short term complications [Срок оценки: Post-operatively at 30 days]
• Incidence of long term complications [Срок оценки: Following surgery up to 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UT Southwestern — Dallas

Публикации

• Farr DE, Haddock NT, Tellez J, Radi I, Alterio R, Sayers B, Zeh H 3rd. Safety and Feasibility of Single-Port Robotic-Assisted Nipple-Sparing Mastectomy. JAMA Surg. 2024 Mar 1;159(3):269-276. doi: 10.1001/jamasurg.2023.6999. PMID 38231502

Идентификаторы

NCT: NCT05245812 · STU-2022-0091

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗