Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06593132

Single Port Endoscopic Breast Conserving Surgery

The center plans to carry out a prospective clinical study of single hole total endoscopic breast conserving surgery for early breast cancer compared with open breast conserving surgery, to provide high-level evidence-based medical evidence for the development of endoscopic breast conserving surgery for early breast cancer.

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location status: Recruiting

Location contact

Yu Ren, MD,PhD

CONTACT

[email protected]

13700222161

About this study

Data show that breast cancer has surpassed lung cancer asthemost prevalent malignant tumor in the world, and traditional open surgery is highly invasive and has poor cosmetic results. This study investigates the results of endoscopic breast- conserving surgery(E-BCS) versus conventional breast-conserving surgery(C-BCS) in the treatment of patients with early-stage breast cancer and to compare the advantages and disadvantages of the two surgical procedures, so as to provide the best evidence for the rational choice of the procedure by both doctors and patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Breast cancer confirmed by pathology;
  • Tumor <5 cm, TNM stage 0-II;
  • Single Port Endoscopic or traditional open surgery; (4)20 to 70 years old female patients.

Exclusion criteria

  • Bilateral breast cancer;
  • Reconstruction after breast conserving surgery ;
  • Basic information is not complete;
  • Breast conserving surgery was converted to modified radical resection or subcutaneous adenoidectomy.

Treatment and study plan

endoscopic breast conserving surgery

Procedure

Breast endoscopy technology completes complex surgical operations through small incisions, achieving aesthetically pleasing results while ensuring tumor safety.

Primary outcomes

  1. Six months after operation SURVIVAL EFFECTS

    Time frame: From enrollment to the end of 6 months after surgery

    To compare the overall survival (OS) within 6 months after single-port endoscopic breast-conserving surgery and open breast-conserving surgery.

Secondary outcomes

  1. Intraoperative blood loss

    Time frame: From the beginning to the end of the operation

    To compare the total blood loss between single-port endoscopic breast-conserving surgery and open breast-conserving surgery.

  2. Postoperative drainage volume in the first three days after breast conserving surgery

    Time frame: 3 days after surgery

    The total drainage volume in the first three days after breast conserving surgery was compared between single-port endoscopic breast conserving surgery and open breast conserving surgery.

  3. Length of surgical incision

    Time frame: 1 week after surgery

    The total incision length was compared between single-port endoscopic breast-conserving surgery and open breast-conserving surgery.

Study contacts

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

Zhaoli Nan, bacheior

CONTACT

[email protected]

15114822852

Sponsors and collaborators

Lead sponsor

Ren,Yu

Other

Registry information

Official study title

Prospective Clinical Study of Single Port Endoscopic Breast Conserving Surgery or Open Breast Conserving Surgery for Early Breast Cancer

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 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.