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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05179304
Other study ID # 2021-KY-124-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 18, 2022
Est. completion date November 2022

Study information

Verified date February 2022
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Shicheng Su, M.D.,Ph.d.
Phone +8613631304227
Email sushch@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 109
Est. completion date November 2022
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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


Intervention

Procedure:
Oncoplastic technique with a droplet-shaped glandular flap
A droplet-shaped glandular flap (DSG) is in a shape of a water drop, with the pedicle at the top of the defect and the base underlying nipple-areolar complex (NAC). It runs from the outer upper quadrant to the center along a line parallel to the radial line. We harvest a DSG flap by dissociating the supplement mammary gland from the lateral of the defect after resection, developing deep to the pectoralis fascia, from the cusp at the defect and the round pore underlying nipple-areolar complex (NAC). The DSG flap was rotated inwards around the cusp, reaching the top of the defect. This tailored redistribution allowed the defects to be "plugged" with the lateral glandular flaps.

Locations

Country Name City State
China Shicheng Su Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

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