Endoscopic Breast Conserving Surgery With Intra-operative Navigation System

Endoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05458414
• Other study ID #: SYSKY-2022-117-01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: July 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Shicheng Su, M.D., Ph.D.
• Phone: +86 13631304227
• Email: sushch[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast-Conserving Surgery
• Endoscopy
• Esthetics

Intervention

Device:
• Intra-operative Navigation System
In the experimental group,a navigation technology was used to identify tumor margins during the surgery.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Reoperation Rate	the rate that margins needs to be reoperated due to incomplete excision	one month
Secondary	Patients' Feedback	Breast Q assessment. The assessment includes seven questionnaires that shows patients'feedback post-operatively.	half a year to one year