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

NCT06671249 | Not Yet Recruiting

• 1 other identifier: 2024-1251
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• breast appearance satisfaction

  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.

  2 years

• breast aesthetic scores

  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.

  2 years

Secondary Outcomes (3)

• Complications

  1 year

• Quality of Life

  1 year

• local recurrence rate

  2 years

Study Arms (2)

Laparoscopic breast-conserving surgery

EXPERIMENTAL

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

Procedure: Laparoscopic breast-conserving surgery

Traditional open breast-conserving surgery

ACTIVE COMPARATOR

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

Procedure: Traditional open breast-conserving surgery

Interventions

Laparoscopic breast-conserving surgery PROCEDURE

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

Laparoscopic breast-conserving surgery

Traditional open breast-conserving surgery PROCEDURE

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

Traditional open breast-conserving surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Xiaochen Wang

Hangzhou, Zhejiang, 31000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xiaochen - Wang, Doctorate

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaochen - Wang, Doctorate

CONTACT

+86 13958161286; wangxiaochen@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 4, 2024
• Study Start: October 25, 2024
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): October 25, 2027
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)