Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.
Detailed description
In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required to ensure the efficiency of cure. Also, less scars and breast preservation has becoming more and more important for patients' acceptance to the treatment. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.
Interventions
PROCEDURELaparoscopic breast-conserving surgery
Use laparoscopic surgery to treat breast cancer patients who want and have the opportunity to preserve their breast
PROCEDURETraditional open breast-conserving surgery
Treat breast cancer patients who want and have the opportunity to preserve their breast with traditional open breast-conserving surgery.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female over the age of 18 * Preoperative pathologically confirmed invasive breast cancer or ductal carcinoma in situ * Clinical classification T1, T2 (maximum tumor diameter ≤5cm) * Single-center tumor (preoperative confirmation by B-ultrasound, MRI and other imaging examinations) * No clinical or imaging evidence of distant metastasis * Able and willing to sign informed consent
Exclusion criteria
* Tumor in the lower inner quadrant * Tumor in multiple quadrants * Imaging or intraoperative pathology indicates tumor invasion of the nipple areola, skin, or pectoralis major * Locally advanced breast cancer patients are undergoing neoadjuvant therapy * Tumor in multiple quadrants * Have been participating in other clinical trials, which may affect the participation in this trial * Previous history of breast cancer (patients with recurrence after ipilateral breast-conserving surgery) * Pregnant and lactating women * Patients with severe cardiopulmonary disease or severely impaired lung function are not suitable for surgical establishment of an air cavity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| breast appearance satisfaction | 2 years | Whether laparoscopic breast-conserving and traditional open breast-conserving had significant differences postoperative cosmetic outcomes. One of the evaluation indicators is breast appearance satisfaction. Our study chooses BREAST-Q questionnaire to evaluate patients' breast appearance satisfaction. |
| breast aesthetic scores | 2 years | Whether laparoscopic breast-conserving and traditional open breast-conserving had significant differences postoperative cosmetic outcomes. Another of the evaluation indicators is breast aesthetic scores. We will invite two Plastic surgeons who did not participate in the study to judge patients' photographs, which is taken 18 months after the surgery, according to the Harris evaluation criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 1 year | The study focus on intraoperative/postoperative complications between endoscopic breast-conserving and traditional open breast-conserving, including bleeding, hematoma, seroma, poor wound healing, nipple/areola necrosis, incision infection and incision dehiscence. |
| Quality of Life | 1 year | Whether laparoscopic breast-conserving and traditional open breast-conserving have difference in quality of life. The study measures the quality of life with the EORTC QLQ BR23 questionnaire launched by European Organization for Research and Treatment of Cancer. |
| local recurrence rate | 2 years | Whether laparoscopic breast-conserving and traditional open breast-conserving have difference in local recurrence rate. If local recurrence appears, record the time and location of recurrence. |
Countries
China
Contacts
Primary ContactXiaochen - Wang, Doctorate
Outcome results
None listed