Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)

Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Ductal Breast Carcinoma In Situ; Prophylactic Mastectomy
• Intervention / Treatment: Procedure: Robot-assisted Nipple Sparing Mastectomy; Other: Survey Administration; Device: RNSM

Detailed Description

With the advances of breast reconstruction after mastectomy for the treatment of breast diseases including breast cancer, surgical techniques have evolved to preserve the skin flaps and nipple areolar complex (NAC) to give better aesthetic outcome without compromising outcome. Mastectomy that preserves the NAC is called nipple sparing mastectomy (NSM). NSM can provide major psychosocial benefits for patients but is technically demanding and challenging to perform. Total mammary glandular excision in NSM can be technically challenging due to small size of the incision and poor visualization of dissection plane. Recent studies demonstrate feasibility and safety of performing minimally invasive robot-assisted NSM (RNSM). The technique of RNSM is still novel.

This is a single-arm pilot study for feasibility and safety of RNSM.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Surgical candidates, per standard of care for:

  • Nipple sparing resection and reconstruction OR
  • Prophylactic mastectomy for risk reduction mastectomy OR
  • Treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
• Surgical candidates for open NSM, per standard of care, with regards to patient anatomic factors and tumor location
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Pregnant or nursing women

• Patients with:

  • Inflammatory breast cancer
  • Skin involvement with tumor
  • Pre-operative diagnosis (radiological or pathologic) of nipple-areola complex involvement with tumor
  • Grade 3 ptosis of nipple
• Smokers with heavy current use of nicotine (defined as > 20 cigarettes/day)
• Patients that are high risk for anesthesia, as documented in medical record
• Patients that do not have the ability to give informed consent
• Prisoner status at surgical clinic visit
• Bra cup size greater than C cup
• Previous thoracic radiation history (for any reason)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive care (RNSM, surveys); RNMS Surveys	Procedure: Robot-assisted Nipple Sparing Mastectomy; Under RNSM; Other: Survey Administration; ancillary correlative; Device: RNSM; Robot-assisted Nipple Sparing Mastectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of removal of breast gland en bloc through RNSM	Measure number of patients who had breast removed en bloc through RNSM incision.	Up to 1 year
Complication rate of patients with bleeding requiring re-operation	Number of patients with bleeding requiring re-operation after RNSM.	Up to 1 year
Complication rate of patients with infection requiring antibiotics or re-operation	Number of patients with infection after surgery requiring antibiotics or re-operation.	Up to 1 year
Complication rate of patients with Mastectomy flap (SKIN flap score)	Number of patients with mastectomy flap or nipple-areolar complex necrosis as measured using the SKIN flap score after surgery. Score of A1 indicates normal skin, D4 indicates total full thickness necrosis.	Up to 1 year
Perioperative Outcomes investigating the total duration of surgical time	Investigate the total duration of the operation (surgical time data),	Up to 1 year
Perioperative Outcomes investigating length of surgery time	Investigate the total duration of the operation (surgical time data) of each patient	Up to 1 year
Perioperative Outcomes investigating the length of hospitalization	Investigate the length of hospitalization for each patient	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey	Surgery Task Load Index (SURG-TLX) survey from each surgeon performing surgery.	Up to 1 year
Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire	Musculo-Skeletal Questionnaire (NMSQ) from each surgeon performing surgery.	Up to 1 year
Patient Reported Outcomes	Monofilament testing to test for sensation recovery after surgery from each participant. Semmes Weinstein monofilament exam; sensation to series of monofilament with different thickness, compare sensation to preoperative exam.	Up to 1 year
Patient Reported Outcomes	Patient satisfaction with the breast after surgery measured by BREAST-Q survey. Lowest score = 0, highest = 100 with higher scores indicating better outcomes / quality of life.	Up to 1 year

Collaborators and Investigators

• Sponsor: William Carson
• Investigators: Principal Investigator: William Carson, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

General Publications

• Park KU, Lee S, Sarna A, Chetta M, Schulz S, Agnese D, Grignol V, Carson W, Skoracki RJ. Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). BMJ Open. 2021 Nov 15;11(11):e050173. doi: 10.1136/bmjopen-2021-050173.

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Carcinoma in Situ; Breast Neoplasms; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast
• Other Study ID Numbers: OSU-19199; NCI-2020-05349 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes