EICHORCondition: Breast Neoplasms · Sponsor: Guangzhou Women and Children's Medical Center
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This is a retrospective observational study comparing the accuracy and safety of robotic-assisted versus endoscopic-assisted sentinel lymph node biopsy (SLNB) in patients with breast cancer. The study aims to evaluate the detection accuracy, false-negative rate, and perioperative safety profile between the two minimally invasive techniques, as well as to assess postoperative complications, pain, upper limb function, quality of life, and long-term oncological outcomes including axillary recurrence and survival. Data will be extracted from routine clinical records. The study will compare the robotic group and the endoscopic group with respect to the following outcome measures: 1.Accuracy-related outcomes: sentinel lymph node detection rate, number of sentinel lymph nodes identified, and false-negative rate, sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV). All accuracy metrics are calculated with reference to final axillary lymph node status confirmed by completion ALND or long-term clinical follow-up; 2.Safety-related outcomes: perioperative parameters including operative time, estimated blood loss, length of hospital stay, and duration of postoperative drainage; postoperative complications including but not limited to seroma, hematoma, wound infection, and lymphedema; postoperative pain assessed by the Verbal Rating Scale (VRS); upper limb function assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) score; and quali…
This description comes directly from the study's public registry record.
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Inclusion Criteria: * Female patients aged 18 to 80 years; * Patients with pathologically confirmed breast cancer; * Patients with cN0 or pre-neoadjuvant therapy cN1 breast cancer who are planned to undergo sentinel lymph node biopsy (SLNB); * Patients who provide written informed consent; * Eastern Cooperative Oncology Group performance status (ECOG PS): 0-1. Exclusion Criteria: * Clinical nodal stage greater than cN1 or inflammatory breast cancer; * Prior history of ipsilateral axillary or breast surgery; * Presence of distant metastasis (Stage IV); * Allergy to indocyanine green (ICG) or carbon nanoparticles; * Patients with other malignant tumors or severe comorbidities that render them unable to tolerate surgery.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Guangzhou Women and Children's Medical Center, Guangzhou Medical University | Guangzhou, Guangdong, China | — |
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Source record: clinicaltrials.gov/study/NCT07741734