Clinical trial NCT06671249: Comparing the Safety and Cosmetic Outcomes Between Laparoscopic Versus Traditional Open Breast-conserving Surgery
Official title: A Multicenter, Open and Prospective Randomized Controlled Trial Comparing the Safety and Cosmetic Outcomes of Laparoscopic Breast-conserving Surgery Versus Traditional Open Breast-conserving Surgery.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: breast appearance satisfaction
timeFrame: 2 years
measure: breast aesthetic scores
timeFrame: 2 years
Secondary outcomes:
measure: Complications
timeFrame: 1 year
measure: Quality of Life
timeFrame: 1 year
measure: local recurrence rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xiaochen Wang
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Xiaochen - Wang, Doctorate
role: PRINCIPAL_INVESTIGATOR
References: