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)

4 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Robot-assisted Nipple Sparing Mastectomy for breast cancer?

Research shows that robot-assisted nipple-sparing mastectomy (RNSM) is effective in reducing visible scars and improving quality of life compared to conventional methods. Studies also indicate that RNSM has comparable safety and cancer control outcomes to traditional surgery, with some reports highlighting fewer complications. ^{1 2 3 4 5}

Is robot-assisted nipple-sparing mastectomy safe for humans?

Robot-assisted nipple-sparing mastectomy generally has a lower rate of complications compared to the traditional method, although it takes longer to perform. More studies are needed to confirm these findings, but early results are promising for safety. ^{2 6 7 8 9}

How is robot-assisted nipple-sparing mastectomy different from other breast cancer treatments?

Robot-assisted nipple-sparing mastectomy is unique because it uses advanced robotic technology to perform the surgery with high precision, resulting in a smaller, less visible scar and better preservation of the breast's blood supply. This approach also eliminates the need for incisions on the breast itself, which can improve cosmetic outcomes compared to traditional open surgery. ^{1 2 10 11 12}

What is the purpose of this trial?

This is a pilot study to determine safety, efficacy, and potential risks of robot assisted nipple sparing mastectomy (RNSM), by utilizing the daVinci surgical system.

Research Team

William Carson, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Breast cancer robotic nipple sparing mastectomy: evaluation of several surgical procedures and learning curve. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Robot-assisted nipple-sparing mastectomy: systematic review. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Post-Operative Complications and Nipple Necrosis Rates Between Conventional and Robotic Nipple-Sparing Mastectomy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Surgical and Oncologic Outcomes of Robotic and Conventional Nipple-Sparing Mastectomy with Immediate Reconstruction: International Multicenter Pooled Data Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Robot-assisted Nipple-sparing Mastectomy With Immediate Breast Reconstruction: An initial Experience of the Korea Robot-endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG). [2022]

6. England 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Breast reconstruction following nipple-sparing mastectomy: predictors of complications, reconstruction outcomes, and 5-year trends. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Nipple- and areola-sparing mastectomy for the treatment of breast cancer. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Impact of surgical complications on patient reported outcomes (PROs) following nipple sparing mastectomy. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Robotic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: Surgical Technique. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. [2022]