Breast NeoplasmsNCT07693361
Robotic-Assisted Versus Endoscopic-Assisted Axillary Lymph Node Dissection in Breast Cancer
An observational study of Breast Neoplasms, run by Guangzhou Women and Children's Medical Center at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms
- How many people
- 127 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2021to 1 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Foshan Fosun Chancheng Hospital
Foshan, Guangdong
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, Guangdong, 510000
About this study
Official title: A Retrospective Study Comparing the Safety and Efficacy of 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:
- 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;
- 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;
- Postoperative complications: including but not limited to seroma, hematoma, wound infection, lymphedema, and shoulder dysfunction;
- 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;
- 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.
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, axillary lymph node dissection, intercostobrachial nerve, Robotic-Assisted Surgery, Endoscopic-Assisted Surgery, Quality of Life, sensory function
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Within 30 days post-surgery and at long-term follow-up assessments
Recurrence and Metastasis Events
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.
Measured: Up to 5 years post-surgery, with follow-up duration based on data availability from routine clinical records
Survival Outcomes
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.
Measured: Up to 5 years post-surgery, with follow-up duration based on data availability from routine clinical records
Operative Time
Operative time (minutes) is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups.
Measured: During surgery, recorded in the operative note
Intraoperative Blood Loss
Intraoperative Blood Loss(mL) is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups.
Measured: During surgery, recorded in the operative note
The number of Lymph Nodes Dissected
The number of lymph nodes dissected is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups.
Measured: During surgery, recorded in the operative note
Postoperative Recovery Parameters
Length of hospital stay (days) and duration of postoperative drainage (days) are compared between the robotic-assisted and endoscopic-assisted groups.
Measured: During index hospitalization and within 30 days post-surgery
Intercostobrachial Nerve Identification and Preservation
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.
Measured: During surgery, recorded in the operative note
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Oct 2021
- Primary completion1 May 2025
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haiyanli, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693361
- Sponsor's protocol ID
- 236A01
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the retrospective nature of this study and concerns regarding patient privacy and confidentiality. The data were extracted from routine clinical records under a waiver of informed consent granted by the ethics committee, and the original consent forms did not include provisions for data sharing with external researchers. Therefore, IPD sharing is not planned. However, summarized data and analytical codes may be available from the corresponding author upon reasonable request, subject to institutional and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Comparing the Safety and Efficacy of Robotic-Assisted Versus Endoscopic-Assisted Axillary Lymph Node Dissection in Breast Cancer
- ClinicalTrials.gov ID
- NCT07693361
- Acronym / sponsor ID
- 236A01
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, axillary lymph node dissection, intercostobrachial nerve, Robotic-Assisted Surgery, Endoscopic-Assisted Surgery, Quality of Life, sensory function
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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;
- Postoperative complications: including but not limited to seroma, hematoma, wound infection, lymphedema, and shoulder dysfunction;
- 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;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
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)
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)
Postoperative Complications
Time frame: Within 30 days post-surgery and at long-term follow-up assessments
Recurrence and Metastasis Events
Time frame: Up to 5 years post-surgery, with follow-up duration based on data availability from routine clinical records
Survival Outcomes
Time frame: Up to 5 years post-surgery, with follow-up duration based on data availability from routine clinical records
Operative Time
Time frame: During surgery, recorded in the operative note
Intraoperative Blood Loss
Time frame: During surgery, recorded in the operative note
The number of Lymph Nodes Dissected
Time frame: During surgery, recorded in the operative note
Postoperative Recovery Parameters
Time frame: During index hospitalization and within 30 days post-surgery
Intercostobrachial Nerve Identification and Preservation
Time frame: During surgery, recorded in the operative note
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the retrospective nature of this study and concerns regarding patient privacy and confidentiality. The data were extracted from routine clinical records under a waiver of informed consent granted by the ethics committee, and the original consent forms did not include provisions for data sharing with external researchers. Therefore, IPD sharing is not planned. However, summarized data and analytical codes may be available from the corresponding author upon reasonable request, subject to institutional and ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Guangzhou Women and Children's Medical Center at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.