Endoscopic Breast Conserving Surgery With Intra-operative Navigation System

NCT05458414 | Unknown

• 1 other identifier: SYSKY-2022-117-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast-Conserving Surgery; Negative Surgical Margins; Endoscopy; Esthetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ABNSW system (Aesthetic Outcome)

  half a year to one year

• Reoperation Rate

  one month

• Patients' Feedback

  half a year to one year

Study Arms (1)

Endoscopic Breast Conserving Surgery With Intra-operative Navigation System

EXPERIMENTAL

Surgerons will use Intra-operative navigation system during the surgery to delineate the margins of tumor.

Device: Intra-operative Navigation System

Interventions

Intra-operative Navigation System DEVICE

In the experimental group，a navigation technology was used to identify tumor margins during the surgery.

Also known as: Medtronic Stealth Station S7 Navigation System

Endoscopic Breast Conserving Surgery With Intra-operative Navigation System

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Margins of Excision

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shicheng Su, M.D., Ph.D.

CONTACT

+86 13631304227; sushch@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Shuhua Breast Cancer Research Center of Sun Yat- sen Memorial Hospital

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 14, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)