Aesthetic Outcomes of Oncoplastic Breast Surgery for Breast Cancer in the Upper Inner Quadrant

Sun Yat-sen University

Status

Unknown

Conditions

Breast Cancer

Aesthetic Outcomes

Oncoplastic Breast Surgery

Treatments

Procedure: Oncoplastic technique with a droplet-shaped glandular flap

Study type

Interventional

Funder types

Other

Identifiers

NCT05179304

2021-KY-124-001

Details and patient eligibility

About

Oncoplastic breast surgery, combining oncological resection with plastic surgical techniques, has emerged as an important surgical strategy to optimize conventional breast-conserving surgery. The upper inner quadrant is one of the most difficult and challenging tumor locations for surgeons to perform oncoplastic breast surgery. There is a pressing need to develop a simple and effective oncoplastic surgical technique to cope with the unfavorable anatomy and location of tumors in the UIQ. Here, we present a new oncoplastic volume displacement technique for UIQ using the DSG flap. This trial was design to estimate the aesthetic outcomes of an oncoplastic technique using a droplet-shaped glandular flap for breast cancer in the upper inner quadrant.

Enrollment

109 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed the informed consent.
Female aged between 18 and 70 years.
Pathologically diagnosed operable breast cancer.
WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Cancer located in the upper inner quadrant; Single tumor or multiple tumors in the same quadrant.
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 breast conserving surgery.

Exclusion criteria

Multifocal or multicentric disease.
Tumor localized in the central quadrant or the distance to the nipple < 2 cm；
Diffused calcifications with fine plemorphic or fine linear or fine-linear branching morphology.
The ratio of tumor to breast > 20%;
The diameter of tumor is up to 4 cm;
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.