Clinical trial NCT05458414: Endoscopic Breast Conserving Surgery With Intra-operative Navigation System
Official title: Clinical Impacts of Margin Assessment and Aesthetic Outcomes of Endoscopic Breast Conserving Surgery With Intra-operative Navigation System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast-Conserving Surgery
Negative Surgical Margins
Endoscopy
Esthetics
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Final Margin Assessment
timeFrame: two weeks to one month
Secondary outcomes:
measure: ABNSW system (Aesthetic Outcome)
timeFrame: half a year to one year
measure: Reoperation Rate
timeFrame: one month
measure: Patients' Feedback
timeFrame: half a year to one year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References: