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NCT Number: NCT07693361

Robotic-Assisted Versus Endoscopic-Assisted Axillary Lymph Node Dissection in Breast Cancer

This is a multicenter, retrospective observational study comparing the safety and efficacy of robotic-assisted versus endoscopic-assisted axillary lymph node dissection (ALND) in patients with node-positive breast cancer. The study aims to evaluate the protective effect on the intercostobrachial nerve (ICBN), perioperative outcomes, postoperative complications, and quality of life between the two minimally invasive techniques, as well as to assess 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. ICBN-related sensory outcomes: incidence of sensory impairment (light touch, pinprick, cold, and warm sensations) in four key regions innervated by the ICBN (medial upper arm, axilla, lateral chest wall, and upper chest wall) assessed using standardized bedside sensory testing and sensory scoring systems; 2. Perioperative outcomes: including but not limited to operative time, estimated blood loss, number of lymph nodes dissected, length of hospital stay, drainage duration and axillary neurotomy; 3. Postoperative complications: including but not limited to seroma, hematoma, wound infection, lymphedema, and shoulder dysfunction; 4. Pain and functional outcomes: including but not limited to 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 quality of life assessed by the Functional Assessment of Cancer Therapy - Breast + 4 (FACT B+4) questionnaire; 5. Oncological outcomes: including but not limited to axillary recurrence, locoregional recurrence, distant metastasis, disease-free survival (DFS), and overall survival (OS), with a minimum follow-up period to be determined based on data availability.

This study has been approved by the Research Ethics Committee of Guangzhou Medical University Affiliated Women and Children's Medical Center. A waiver of informed consent has been granted due to the retrospective nature of the study. All patient data will be anonymized and kept confidential. Statistical analyses will be performed using R, SPSS and GraphPad Prism, with a P value < 0.05 considered statistically significant.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Foshan Fosun Chancheng Hospital, Foshan, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • pathologically confirmed breast cancer;
  • clinical N1-N3 stage or confirmation of lymph node metastasis by intraoperative frozen pathology;
  • Enlarged lymph nodes without significant adhesion to the axillary vessels or nerves;
  • Ability to comprehend the research questions;
  • Provision of informed consent and cooperation with the investigation;
  • No history or current diagnosis of mental illness or impaired consciousness;
  • ECOG PS 0-1.

Exclusion criteria

  • Patients without lymph node metastasis;
  • Patients who refuse surgery;
  • Breast cancer patients with cognitive impairment, altered mental status, or inability to clearly express their feelings;
  • Critically ill patients;
  • Patients with other malignant tumors or severe medical conditions that render them unable to tolerate surgery.

Treatment and study plan

Primary outcomes

  1. Incidence of Sensory Impairment in Intercostobrachial Nerve Innervated Regions

    Time frame: At postoperative follow-up assessments (e.g., 1 month, 3 months, 6 months, and 12 months after surgery, with additional long-term follow-up based on data availability)

    Sensory function assessed in four key regions innervated by the intercostobrachial nerve (ICBN): medial upper arm, axilla, lateral chest wall, and upper chest wall. Four sensory modalities are evaluated using standardized bedside sensory testing: light touch, pinprick, cold sensation, and warm sensation. The evaluation of sensory impairment includes the following dimensions: (1) type of sensory impairment (e.g., hypoesthesia, hyperesthesia, paresthesia, or anesthesia); (2) location of impairment (specific ICBN-innervated regions affected); (3) extent/area of impairment (measured as the involved surface area within each region); and (4) proportion of impairment (the percentage of patients with sensory impairment in each region and modality). These sensory outcomes are compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups.

Secondary outcomes

  1. Quality of Life Assessed by Cancer Therapy - Breast + 4

    Time frame: At postoperative follow-up visits (1 month, 3 months, 6 months, and 12 months after surgery, with additional long-term follow-up based on data availability)

    Health-related quality of life is evaluated using the Functional Assessment of Cancer Therapy - Breast + 4 (FACT B+4) questionnaire, which assesses physical, social, emotional, and functional well-being, with additional breast cancer-specific concerns.

  2. Upper Limb Function Assessed by Disabilities of the Arm, Shoulder and Hand Scores

    Time frame: At postoperative follow-up visits (1 month, 3 months, 6 months, and 12 months after surgery, with additional long-term follow-up based on data availability)

    Upper limb function is assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, which evaluates the ability to perform daily activities and the severity of upper extremity symptoms. Scores are compared between the robotic-assisted and endoscopic-assisted groups.

  3. Postoperative Complications

    Time frame: Within 30 days post-surgery and at long-term follow-up assessments

    The incidence of postoperative complications is compared between the robotic-assisted and endoscopic-assisted groups, including but not limited to: seroma, hematoma, wound infection, surgical site infection, lymphedema of the ipsilateral upper extremity, shoulder dysfunction, and other procedure-related adverse events. All complications are graded according to the Clavien-Dindo classification system.

  4. Recurrence and Metastasis Events

    Time frame: Up to 5 years post-surgery, with follow-up duration based on data availability from routine clinical records

    The incidence of axillary recurrence, locoregional recurrence, and distant metastasis is compared between the robotic-assisted and endoscopic-assisted ALND groups, with all events confirmed by histopathological or radiological evidence.

  5. Survival Outcomes

    Time frame: Up to 5 years post-surgery, with follow-up duration based on data availability from routine clinical records

    Disease-free survival (DFS), defined as time from surgery to first recurrence, metastasis, or death, and overall survival (OS), defined as time from surgery to death from any cause, are compared between the two groups.

  6. Operative Time

    Time frame: During surgery, recorded in the operative note

    Operative time (minutes) is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups.

  7. Intraoperative Blood Loss

    Time frame: During surgery, recorded in the operative note

    Intraoperative Blood Loss(mL) is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups.

  8. The number of Lymph Nodes Dissected

    Time frame: During surgery, recorded in the operative note

    The number of lymph nodes dissected is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups.

  9. Postoperative Recovery Parameters

    Time frame: During index hospitalization and within 30 days post-surgery

    Length of hospital stay (days) and duration of postoperative drainage (days) are compared between the robotic-assisted and endoscopic-assisted groups.

  10. Intercostobrachial Nerve Identification and Preservation

    Time frame: During surgery, recorded in the operative note

    The number of intercostobrachial nerve identified, the number of intercostobrachial nerve preserved, and intercostobrachial nerve grading (based on intraoperative anatomical classification) are compared between the robotic-assisted and endoscopic-assisted groups.

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Registry information

Official study title

A Retrospective Study Comparing the Safety and Efficacy of Robotic-Assisted Versus Endoscopic-Assisted Axillary Lymph Node Dissection in Breast Cancer

Important dates

Study start
2021
Primary completion
2025
Study completion
2028
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

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.

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