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

NCT ID: NCT06671249

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-25
• Study Completion Date: 2027-10-25

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic breast-conserving surgery

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

Group Type: EXPERIMENTAL

Laparoscopic breast-conserving surgery

Intervention Type: PROCEDURE

Use laparoscopic surgery to treat breast cancer patients who want and have the opportunity to preserve their breast

Traditional open breast-conserving surgery

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

Group Type: ACTIVE_COMPARATOR

Traditional open breast-conserving surgery

Intervention Type: PROCEDURE

Treat breast cancer patients who want and have the opportunity to preserve their breast with traditional open breast-conserving surgery.

Interventions

Laparoscopic breast-conserving surgery

Use laparoscopic surgery to treat breast cancer patients who want and have the opportunity to preserve their breast

Intervention Type: PROCEDURE

Traditional open breast-conserving surgery

Treat breast cancer patients who want and have the opportunity to preserve their breast with traditional open breast-conserving surgery.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaochen - Wang, Doctorate

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Xiaochen Wang

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Xiaochen - Wang, Doctorate

Role: CONTACT

wangxiaochen@zju.edu.cn

+86 13958161286

Facility Contacts

Xiaochen - Wang, Doctorate

Role: primary

wangxiaochen@zju.edu.cn

+86 13958161268

Other Identifiers

2024-1251

Identifier Type: -

Identifier Source: org_study_id