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

NCT07693361 | Active Not Recruiting

• 1 other identifier: 236A01
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 2

Brief Summary

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. 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. 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. 3.Postoperative complications: including but not limited to seroma, hematoma, wound infection, lymphedema, and shoulder dysfunction;
4. 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. 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.

Conditions

Breast Neoplasms

Keywords

breast cancer; axillary lymph node dissection; intercostobrachial nerve; Robotic-Assisted Surgery; Endoscopic-Assisted Surgery; Quality of Life; sensory function

Outcome Measures

Primary Outcomes (1)

• Incidence of Sensory Impairment in Intercostobrachial Nerve Innervated Regions

  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.

  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)

Secondary Outcomes (10)

• Quality of Life Assessed by Cancer Therapy - Breast + 4

  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 Assessed by Disabilities of the Arm, Shoulder and Hand Scores

  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)

• Postoperative Complications

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

• Recurrence and Metastasis Events

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

• Survival Outcomes

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

Study Arms (2)

R-ALND

Participants with breast cancer who underwent robotic-assisted axillary lymph node dissection.

E-ALND

Participants with breast cancer who underwent endoscopic-assisted axillary lymph node dissection.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer who underwent either robotic-assisted or endoscopic-assisted axillary lymph node dissection at the Department of Breast and Thyroid Surgery Center, Guangzhou Medical University Affiliated Women and Children's Medical Center and Foshan Fosun Chancheng Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (2)

Foshan Fosun Chancheng Hospital

Foshan, Guangdong, China

Location

Guangzhou Women and Children's Medical Center, Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 9, 2026
• Study Start: October 1, 2021
• Primary Completion: May 1, 2025
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)