Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06671249

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic breast-conserving surgery

Procedure

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

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.

Primary outcomes

  1. breast appearance satisfaction

    Time frame: 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.

  2. breast aesthetic scores

    Time frame: 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 outcomes

  1. Complications

    Time frame: 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.

  2. Quality of Life

    Time frame: 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.

  3. local recurrence rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaochen - Wang, Doctorate

CONTACT

[email protected]

+86 13958161286

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.