Comparing the Safety and Cosmetic Outcomes Between Laparoscopic Versus Traditional Open Breast-conserving Surgery

Zhejiang University

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Procedure: Laparoscopic breast-conserving surgery; Procedure: Traditional open breast-conserving surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06671249

2024-1251

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 2 patient groups

Laparoscopic breast-conserving surgery

Experimental group

Description:

Subjects who is going to accept laparoscopic breast-conserving surgery.

Treatment:

Procedure: Laparoscopic breast-conserving surgery

Traditional open breast-conserving surgery

Active Comparator group

Description:

Subjects who is going to accept traditional open breast-conserving surgery.

Treatment:

Procedure: Traditional open breast-conserving surgery