Low Energy Dissection Vs. Electrocautery in Lumpectomy Shaved Surgical Margins

• Conditions: Breast Cancer Female
• Interventions: Device: PhotonBlade vs Bovie for lumpectomy shaved surgical margins

• Registration Number: NCT03718442
• Lead Sponsor: Invuity, Inc.

Brief Summary

The purpose of this study is to compare the qualitative severity and depth of dissection devices' associated thermal artifact in breast lumpectomy shaved margins between the use of electrocautery and low thermal energy dissection, PhotonBlade.

The investigators hypothesize that the use of PhotonBlade would result in a significantly lower qualitative severity and a shorter depth of thermal artifact in breast lumpectomies shaved margins, when compared to electrocautery devices.

Detailed Description

When performing lumpectomy, surgeons have used electrocautery devices as dissecting tools. However, those devices use high thermal energy that might impact the margin cellular architecture and as such the quality of margin assessment by the pathologist. Moreover, recently, modern low thermal energy dissection devices have been introduced to the market. However, the impact of those devices on reducing the thermal injury/artifact on surgical margin has not been well investigated. 4,5 While Ruidaz et al. 2011 data suggest that using the traditional electrosurgical device in place of the low thermal-injury device results in 48% of the close margin samples being negatively converted to false-positive, and in 11% converting from close to false-negative, there is still a need for more studies to further characterize the utility of those devices. 6 PhotonBlade (Invuity, San Francisco, CA, USA) has been approved by United States Food and Drug Administration (FDA). PhotonBlade is a dynamic precision illuminator with enhanced energy delivery dissection device. The dynamic precision illumination is a thermally cool illumination technology that allows a uniformal illumination without glare or shadow. 7 The enhanced energy delivery technology allows low thermal spread, surgeon controlled edge temperature, and wet field use.7 As such, PhontonBlade allows better blade control for achieving adequate visualization, hemostasis, with a minimum collateral damage to the surgical margin tissue. The use of PhotonBlade demonstrated the least penetrating thermal tissue damage/spread when compared to other modern dissection devices (Valleylab Pencil, Valleylab EDGE Coated Pencil, PlasmaBlade 3.0S and PlasmaBlade 4.0).8

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-22
• Last Update Submitted: 2018-10-22
• Study First Posted: 2018-10-24
• Last Update Posted: 2018-10-24
• Study Start: 2019-03-15
• Primary Completion: 2019-12-15
• Study Completion: 2020-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• have aged 18 years old or older.
• have DCIS or Invasive breast cancer that is eligible for breast-conserving surgery.
• have not had previous chest radiotherapy.
• understand the study purpose, requirements, and risks.
• able and willing to give informed consent.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer patients - lumpectomy	PhotonBlade vs Bovie for lumpectomy shaved surgical margins	Women who are 18 years or older, have Ductal carcinoma in situ (DCIS) or invasive breast-conserving surgery, have not had previous chest radiotherapy. 20 patients who meet above study population criteria will be enrolled in this study.Shaved margins for each lumpectomy site will be excised with either Bovie (3 sides) or PhotonBlade (3 sides) for each patient. The effect of PhotonBlade vs Bovie on pathology assessment of lumpectomy shaved surgical margins will be compared.

Primary Outcome Measures

Name	Time	Method
Severity of thermal artifact	Through study completion, an average of 6 months	The severity of the thermal artifact will be assessed by identifying the presence or absence of each the three qualitative severity zones, described previously,6 as below: * Zone I: extensive charring tissue; * Zone II: fused cellular architecture; * Zone III: distressed cellular architecture
Depth of thermal artifact	Through study completion, an average of 6 months	The depth of the thermal artifact will be assessed by reporting the length in micrometer (μm) from the start of Zone 1 to the end of Zone III.