Low Energy Dissection Vs. Electrocautery in Lumpectomy Shaved Surgical Margins

Breast Cancer Female Clinical Trial

Official title:

Low Energy Dissection Vs. Electrocautery Qualitative Severity and Depth of Thermal Artifact in Breast Cancer Lumpectomy Shaved Surgical Margins

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03718442
• Other study ID #: 2018-8984
• Status: Not yet recruiting
• Start date: March 15, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: October 2018
• Source: Invuity, Inc.
• Contact: Dennise D Dalma-Weiszhausz, PhD
• Phone: 6502486662
• Email: ddalma[@]invuity.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 15, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Device:
• PhotonBlade vs Bovie for lumpectomy shaved surgical margins
For each enrolled patient, six shaved margins will be obtained (superior, inferior, medial, lateral, anterior, and posterior). For each patient, electrocautery will be used to obtain 3 of the shaved margins, and PhotonBlade to obtain the other 3 shaved margins. Once the lumpectomy site shaved margins have been obtained, the shaved surgical margins will be evaluated by a pathologist whom is blinded in regards to the dissection device that was used for each margin. The pathologist will be evaluating each shaved margin and reporting the outcomes (qualitative severity and depth of thermal artifact)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Invuity, Inc.	Montefiore Medical Center

References & Publications (6)

ACS. Breast Cancer Facts and Figures 2011-2012. (2012).

Chiappa C, Rovera F, Corben AD, Fachinetti A, De Berardinis V, Marchionini V, Rausei S, Boni L, Dionigi G, Dionigi R. Surgical margins in breast conservation. Int J Surg. 2013;11 Suppl 1:S69-72. doi: 10.1016/S1743-9191(13)60021-7. Review. — View Citation

Haydon E. et al. Assessment of penetrating thermal tissue damage/spread associated with PhotonBlade™, Valleylab™ Pencil, Valleylab™ EDGE™ Coated Pencil, PlasmaBlade® 3.0S and PlasmaBlade® 4.0 for intraoperative tissue dissection using the fresh extirpated porcine muscle model

Pleijhuis RG, Graafland M, de Vries J, Bart J, de Jong JS, van Dam GM. Obtaining adequate surgical margins in breast-conserving therapy for patients with early-stage breast cancer: current modalities and future directions. Ann Surg Oncol. 2009 Oct;16(10):2717-30. doi: 10.1245/s10434-009-0609-z. Epub 2009 Jul 17. Review. — View Citation

Ruidiaz ME, Cortes-Mateos MJ, Sandoval S, Martin DT, Wang-Rodriguez J, Hasteh F, Wallace A, Vose JG, Kummel AC, Blair SL. Quantitative comparison of surgical margin histology following excision with traditional electrosurgery and a low-thermal-injury dissection device. J Surg Oncol. 2011 Dec;104(7):746-54. doi: 10.1002/jso.22012. Epub 2011 Jul 8. — View Citation

Vila J, Gandini S, Gentilini O. Overall survival according to type of surgery in young (=40 years) early breast cancer patients: A systematic meta-analysis comparing breast-conserving surgery versus mastectomy. Breast. 2015 Jun;24(3):175-81. doi: 10.1016/j.breast.2015.02.002. Epub 2015 Feb 23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of thermal artifact	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	Through study completion, an average of 6 months
Primary	Depth of thermal artifact	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.	Through study completion, an average of 6 months