Endoscopic Breast Conserving Surgery With Intra-operative Navigation System

NCT ID: NCT05458414

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-12-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intra-operative Navigation System

Intervention Type: DEVICE

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

Interventions

Intra-operative Navigation System

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

Intervention Type: DEVICE

Other Intervention Names

Medtronic Stealth Station S7 Navigation System

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Shicheng Su

Director of Shuhua Breast Cancer Research Center of Sun Yat- sen Memorial Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

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

Role: CONTACT

sushch@mail.sysu.edu.cn

+86 13631304227

Facility Contacts

Shicheng Su, 510120

Role: primary

sushch@mail.sysu.edu.cn

+86 13631304227

Other Identifiers

SYSKY-2022-117-01

Identifier Type: -

Identifier Source: org_study_id