Robot-assisted Surgery for Breast Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ko Un Park

Disqualifiers: Pregnancy, Inflammatory breast cancer, Smokers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day (surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores robot-assisted surgery for breast cancer treatment, focusing on the safety and effectiveness of using a robot for nipple-sparing mastectomy. The da Vinci surgical system performs this delicate procedure. Ideal participants include candidates for nipple-sparing or risk-reducing mastectomy and those with specific types of breast cancer that have not spread to lymph nodes. The trial aims to improve surgical outcomes and recovery experiences for these patients. As an unphased trial, it offers participants the chance to contribute to pioneering research that could enhance future breast cancer surgeries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that robot-assisted nipple sparing mastectomy is safe?

Research has shown that robot-assisted nipple-sparing mastectomy (RNSM) is generally safe for patients. In one study, none of the 40 patients experienced skin or nipple damage after the procedure. Another study found this type of surgery safe and effective, with good cosmetic results. A review of 82 cases revealed complications in only one patient. Overall, these findings suggest that RNSM is well-tolerated with a low risk of serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Robot-assisted Nipple Sparing Mastectomy (RNSM) is unique because it uses advanced robotic technology to perform breast cancer surgery with precision and minimal invasiveness. Unlike traditional mastectomy techniques, which can be more intrusive and require longer recovery times, RNSM aims to preserve the nipple and surrounding tissue, potentially enhancing cosmetic outcomes and reducing recovery time. Researchers are excited about this approach as it could improve the quality of life for patients by combining effective cancer treatment with better aesthetic results and quicker healing.

What evidence suggests that robot-assisted surgery is effective for breast cancer?

Research has shown that robot-assisted nipple-sparing mastectomy (RNSM), which participants in this trial will undergo, is a promising option for breast cancer surgery. In a study with 40 patients, no cases of skin or nipple tissue death occurred, indicating safety. Another study found that patients healed faster due to smaller incisions compared to traditional methods. Robotic systems like the da Vinci surgical system enable precise surgery, potentially leading to better results and higher patient satisfaction. Overall, these findings suggest that RNSM could be an effective surgical option for breast cancer patients. ^{2 3 5 6 7}

Who Is on the Research Team?

William Carson, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who are candidates for nipple sparing mastectomy or preventive mastectomy due to breast cancer risk. Eligible participants must have a good performance status, meaning they can carry out daily activities with little or no assistance. It's not suitable for pregnant/nursing women, those with large breasts (over C cup), heavy smokers, or anyone with certain complications like severe nipple sagging, previous chest radiation, or tumor involvement in the nipple area.

Inclusion Criteria

You are planning to have surgery to remove the nipple, have a risk-reducing mastectomy, or treat a specific type and stage of breast cancer.

Surgical candidates for open NSM, per standard of care, with regards to patient anatomic factors and tumor location

You have good physical ability to perform daily activities, rated as 0 or 1 by the Eastern Cooperative Oncology Group.

Exclusion Criteria

You have severe drooping of the nipple.

Pregnant or nursing women

Patients that are high risk for anesthesia, as documented in medical record

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robot-assisted nipple sparing mastectomy (RNSM) using the daVinci surgical system

1 day (surgery)

1 visit (in-person)

Follow-up

Participants are monitored for safety, efficacy, and complications post-surgery

Up to 1 year

Regular follow-up visits as needed

What Are the Treatments Tested in This Trial?

Interventions

• Robot-assisted Nipple Sparing Mastectomy

Trial Overview

The study is testing the safety and effectiveness of using a robotic system called daVinci for performing nipple sparing mastectomies in patients with breast cancer. The goal is to see if this high-tech method could be an alternative to traditional surgery.

How Is the Trial Designed?

Group I: Supportive care (RNSM, surveys) Experimental Treatment 3 Interventions

RNMS Surveys

Who Is Running the Clinical Trial?

Ko Un Park

Lead Sponsor

Trials

1

Recruited

4+

William Carson

Lead Sponsor

Trials

3

Recruited

40+

Published Research Related to This Trial

Robotic nipple-sparing mastectomy represents a significant advancement in breast cancer treatment, offering benefits such as shorter scars and better preservation of skin vascularization compared to traditional open techniques.

The authors have conducted over 60 procedures and received approval for a clinical trial to evaluate the feasibility, reproducibility, and safety of this innovative surgical approach, which includes immediate prosthetic breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: Surgical Technique. Sarfati, B., Struk, S., Leymarie, N., et al.[2021]

In a study of 285 patients undergoing 500 nipple-sparing mastectomy procedures, the overall complication rate was low, with infections occurring in only 3.3% and skin necrosis in 5.2%.

Factors such as smoking, higher body mass index, and the type of incision used were identified as significant predictors of complications, while using an inframammary fold incision was associated with fewer complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast reconstruction following nipple-sparing mastectomy: predictors of complications, reconstruction outcomes, and 5-year trends. Colwell, AS., Tessler, O., Lin, AM., et al.[2022]

Robot-assisted nipple-sparing mastectomy is feasible and shows acceptable short-term outcomes, with a study involving 249 procedures across 187 women, indicating it can be performed safely with low intraoperative mortality and no locoregional recurrences observed.

Postoperative complications were noted, including skin issues and specific complications related to the nipple-areolar complex, but overall, the procedure appears to be a viable option for patients undergoing mastectomy, although further assessment is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted nipple-sparing mastectomy: systematic review. Angarita, FA., Castelo, M., Englesakis, M., et al.[2021]

In a study of 63 women undergoing nipple sparing mastectomy (NSM), only 15.9% experienced postoperative complications requiring surgical treatment, indicating that NSM is generally safe.

Importantly, the presence of complications did not lead to a significant decrease in patient-reported outcomes (PROs) one year after surgery, suggesting that NSM maintains its positive impact on quality of life even in the event of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of surgical complications on patient reported outcomes (PROs) following nipple sparing mastectomy. Lagendijk, M., Desantis, S., Nakhlis, F., et al.[2021]

This pilot study aims to evaluate the safety and feasibility of minimally invasive robot-assisted nipple-sparing mastectomy (RNSM) in up to 12 patients, focusing on the successful removal of breast tissue while preserving the nipple-areolar complex.

The study will assess postoperative complications and recovery of breast and nipple sensation, providing valuable insights into the benefits and challenges of RNSM for both patients and surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). Park, KU., Lee, S., Sarna, A., et al.[2022]

Robotic nipple-sparing mastectomy (R-NSM) shows a lower overall complication rate compared to conventional nipple-sparing mastectomy (C-NSM), with a relative risk of 0.68 based on a meta-analysis of six studies involving 63 to 311 mastectomies.

Despite the benefits, R-NSM had a longer operative time and variability in results, indicating that more research is needed to fully understand its effectiveness and oncologic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of robotic nipple-sparing mastectomy versus conventional nipple-sparing mastectomy in women with breast cancer: a systematic review and meta-analysis. De la Cruz-Ku, G., Chambergo-Michilot, D., Perez, A., et al.[2023]

Nipple-sparing mastectomy (NSM) shows a lower hazard ratio for local recurrence compared to modified radical mastectomy (HR 0.28), suggesting it may be a safer option for some patients, although the overall evidence quality is very low due to high risk of bias.

Despite inconclusive results regarding overall survival and complications, NSM appears to offer favorable aesthetic outcomes and improved quality of life compared to traditional mastectomy, based on observational studies involving 6502 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nipple- and areola-sparing mastectomy for the treatment of breast cancer. Mota, BS., Riera, R., Ricci, MD., et al.[2022]

Robotic nipple sparing mastectomy (NSM) is feasible and can be performed effectively, with a standardized technique that combines non-robotic scissors for initial dissection followed by robotic dissection, as demonstrated in a study of 27 patients.

The study found that as surgeons gained experience (the learning curve), the time for surgery and anesthesia decreased, and post-operative complications, particularly skin complications, were significantly lower in patients who underwent the procedure with robotic assistance compared to those who had traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer robotic nipple sparing mastectomy: evaluation of several surgical procedures and learning curve. Houvenaeghel, G., Bannier, M., Rua, S., et al.[2020]

Robotic nipple-sparing mastectomy (RNSM) demonstrated significantly lower rates of postoperative complications and nipple necrosis compared to conventional nipple-sparing mastectomy (CNSM), with a complication rate of 2.2% for RNSM versus 7.8% for CNSM.

Both surgical techniques showed similar oncologic outcomes, indicating that RNSM not only improves cosmetic results but also maintains safety and effectiveness for women undergoing mastectomy for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical and Oncologic Outcomes of Robotic and Conventional Nipple-Sparing Mastectomy with Immediate Reconstruction: International Multicenter Pooled Data Analysis. Park, HS., Lee, J., Lai, HW., et al.[2022]

Citations

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Robot-assisted Nipple Sparing Mastectomy

This study reported that there was no skin or nipple necrosis among the 40 patients undergoing RNSM. A pooled analysis, the Surgical and ...

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In this study, we compared the surgical outcomes of RANSM with those of CNSM in patients with breast cancer. Our results demonstrated that RANSM ...

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“Earlier studies report that if nipple-sparing surgery is done robotically, women are more likely to heal faster due to smaller incisions that ...

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RNSM represents a significant advancement in breast cancer surgery that combines precision with improved patient satisfaction [16, 17]. This ...

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jamanetwork.com

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Safety and Feasibility of Single-Port Robotic-Assisted ...

This study demonstrates that the single-port da Vinci SP was feasible in patients undergoing robotic nipple-sparing mastectomy.

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Robot-assisted Nipple-sparing Mastectomy With Immediate...

This retrospective multicenter study of 82 RANSM cases suggested that RANSM with IBR is safe and feasible for patients with early breast cancer. Only 1 case of ...