Breast cancer
Conditions
Interventions
SMALND group (suspended endoscopic axillary lymph node dissection):Suspended endoscopic axillary lymph node dissection (SMALND), without CO? insufflation, using a mechanical suspension system to creat
MALND group (conventional gas insufflation endoscopic axillary lymph node dissection):Conventional gas insufflation endoscopic axillary lymph node dissection (MALND), relying on CO? insufflation to cr
Sponsors
Zibo Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patient's age is between 18 and 65 years old (inclusive of the boundaries). 2. Breast Cancer Stage and Pathological Features (1) Diagnosis of clinical stage I or II breast cancer. (2) No skin involvement or deep tissue infiltration. (3) Axillary lymph node status of N0 or N1, determined through ultrasound, X-ray, and breast MRI assessments. (4) Staging must follow the TNM classification based on NCCN breast cancer guidelines. 3. Indications for Sentinel Lymph Node Biopsy (SLNB) (1) SLNB is permitted for patients with axillary lymph node status of N0 as assessed by preoperative imaging. (2) Intraoperative frozen section analysis is necessary to confirm the presence of metastasis in the sentinel lymph nodes. 4. Indications for Axillary Microscopic Lymph Node Dissection (Mastoscopic ALND) (1) Patients must meet the criteria for routine axillary lymph node dissection. No prior history of axillary surgery. (2) Clinical examination, ultrasound, and X-ray evaluations of the axillary lymph nodes must be graded below N2. (3) The lymph nodes should not adhere to blood vessels or nerves. 5. Indications for Breast-Conserving Surgery (BCS) (1) The maximum diameter of the tumor should be <=3 cm, allowing the breast to maintain its normal size and shape after surgery. (2) The tumor should not invade the nipple or areola. (3) There should be no multifocal or multiquadrant tumor foci. (4) The patient must be able to tolerate radiotherapy. (5) The tumor should not be located at the margin of the breast and must be operable through an areola incision.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled cardiovascular history, such as unstable angina, congestive heart failure, myocardial infarction within the last 12 months, hemodynamic instability, known left ventricular ejection fraction (LVEF) =2000 IU/mL. (2) Positive HCV antibody test along with HCV RNA testing. 5. Elevated alanine aminotransferase (ALT) levels of >=3×upper limit of normal (ULN) and total bilirubin levels of >=2×ULN (with direct bilirubin to total bilirubin ratio > 35%) are significant. 6. Glomerular filtration rate (GFR) less than 70 mL/min/1.73 m² (calculated using the CKD-EPI Creatinine 2009 Equation) or serum creatinine greater than or equal to the ULN. 7. History of bleeding disorders: (1) Intracranial hemorrhage occurring within six months before screening. (2) Active bleeding within 2 months prior to screening. 8. Female participants who are pregnant or breastfeeding. 9. Participants deemed by the investigator to be unable to tolerate the Research procedure. 10. Any other condition that the investigator believes makes the participant ineligible for the Research. 11. Has a history of participating in clinical trials in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average Daily Axillary Drainage Volume;Intraoperative Blood Loss;Total Duration of Axillary Surgery;Axillary Drain Removal Time; | — |
Countries
China
Contacts
Public ContactLiu Jiaqi
Zibo Central Hospital
Outcome results
None listed