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

Not Applicable

• Conditions: Oncoplastic Breast Surgery; Aesthetic Outcomes; Breast Cancer

• Registration Number: NCT05179304
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-12
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-05
• Study Start: 2022-01-18
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 109

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
aesthetic outcomes	half a year to one year	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.

Secondary Outcome Measures

Name	Time	Method
Local recurrence	half a year to one year	Local recurrence defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall.
Patients complications after surgery	half a year to one year	The occurence of scarring, radiation fibrosis, seroma, fat necrosis and infection
Patients' quality of life	half a year to one year	EORTC QLQ-C30 questionnaire

Trial Locations

Locations (1)

Shicheng Su; 🇨🇳 Guangzhou, Guangdong, China