Endoscopic Breast Conserving Surgery With Intra-operative Navigation System

Clinical Impacts of Margin Assessment and Aesthetic Outcomes of Endoscopic Breast Conserving Surgery With Intra-operative Navigation System

A growing number of Chinese breast cancer patients are diagnosed at a young age. The quality of life of young breast cancer patients has been a critical issue. Breast-conserving surgery (BCS) not only removes the tumor but also maintains the appearance of breast. The Breast Tumor Center of Sun Yat-sen Memorial Hospital is one of the first departments in China to perform breast-conserving surgeries. Endoscopic breast surgery has emerged as a promising surgical approach. However, it is hard to delineate the tumor margins in endoscopic BCS, which restrains its development. In traditional BCS, surgeons determine the tumor border by palpation, which is impossible in endoscopic BCS. For the first time, we performed the intra-operative navigation system-assisted endoscopic breast-conserving surgery, in which the tumor border was accurately delineated using the navigation system.

Study Overview

• Status: Recruiting
• Conditions: Endoscopy; Esthetics; Breast-Conserving Surgery; Negative Surgical Margins
• Intervention / Treatment: Device: Intra-operative Navigation System

Detailed Description

In the study, patients who are female aged between 18 and 70 years, are pathologically diagnosed operable breast cancer, have proper the important organ functions and adjust to the criteria of endoscopic breast conserving surgery. Intraoperative and post-operatitive Margin Assessment will be the primary outcome measure, and aesthetic outcomes, reoperation rate, as well as patients' feedback will be the secondary outcome measure.

• Study Type: Interventional
• Enrollment (Anticipated): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
      • Contact: Shicheng Su, 510120; Phone Number: +86 13631304227; Email: sushch@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Signed the informed consent.
• Female aged between 18 and 70 years.
• Pathologically diagnosed operable breast cancer.
• The important organ functions meet the following criteria:

WBC >=3.0 x 10^9/L; Neutrophilic granulocytes >=1.5×10^9/L; Platelet >=100 x 10^9/L; Hb >=9 g/dL;

• Total bilirubin no more than 1.5 times the normal upper limit (ULN); AST and ALT no more than 1.5 times ULN; AKP no more than 2.5 times ULN;
• Serum creatinine no more than 1.5 times ULN or Clearance rate of creatinine >= 60ml/min;
• Thyroid stimulating hormone (TSH) <= ULN (T3, T4 levels need to be detected simultaneously if abnormalities, the patient can be included if T3, T4 levels is normal);LVEF basement >= 50%.
• Adjust to the criteria of endoscopic breast conserving surgery.

Exclusion Criteria:

• Multifocal or multicentric disease.
• Diffused calcifications with fine plemorphic or fine linear or fine-linear branching morphology.
• Women in the early or intermediate stage of pregnancy;
• Prior history of breast radiation;
• Any severe comorbidities, inability to give informed consent or unavailability for follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Endoscopic Breast Conserving Surgery With Intra-operative Navigation System; Surgerons will use Intra-operative navigation system during the surgery to delineate the margins of tumor.	Device: Intra-operative Navigation System; In the experimental group，a navigation technology was used to identify tumor margins during the surgery.; Other Names: Medtronic Stealth Station S7 Navigation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final Margin Assessment	Pathological results of the margins. Negative margins are defined as "no ink on tumor". Positive marginsare defined according to the Society of Surgical Oncology consensus guidelines as ink on tumor for invasive cancer with or without DCIS component or cancer cells present within 2mm from the inked surface for pure DCIS.	two weeks to one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ABNSW system (Aesthetic Outcome)	ABNSW system. The total score was 15 points, outcomes were good when it was 11-14, fair when it was 6-10, and poor when it was 0-5.	half a year to one year
Reoperation Rate	the rate that margins needs to be reoperated due to incomplete excision	one month
Patients' Feedback	Breast Q assessment. The assessment includes seven questionnaires that shows patients'feedback post-operatively.	half a year to one year

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (ACTUAL): July 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SYSKY-2022-117-01

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: No