Clinical trial NCT04537312: Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)
Official title: Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Ductal Breast Carcinoma In Situ
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
Prophylactic Mastectomy
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of removal of breast gland en bloc through RNSM
timeFrame: Up to 1 year
measure: Complication rate of patients with bleeding requiring re-operation
timeFrame: Up to 1 year
measure: Complication rate of patients with infection requiring antibiotics or re-operation
timeFrame: Up to 1 year
measure: Complication rate of patients with Mastectomy flap (SKIN flap score)
timeFrame: Up to 1 year
measure: Perioperative Outcomes investigating the total duration of surgical time
timeFrame: Up to 1 year
measure: Perioperative Outcomes investigating length of surgery time
timeFrame: Up to 1 year
measure: Perioperative Outcomes investigating the length of hospitalization
timeFrame: Up to 1 year
Secondary outcomes:
measure: Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey
timeFrame: Up to 1 year
measure: Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire
timeFrame: Up to 1 year
measure: Patient Reported Outcomes
timeFrame: Up to 1 year
measure: Patient Reported Outcomes
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: William Carson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.