Breast NeoplasmsNCT07741734
Robotic-Assisted vs. Endoscopic-Assisted Sentinel Lymph Node Biopsy in Breast Cancer
An observational study of Breast Neoplasms, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Oct 2029
- 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 18 to 80 years
- Women only
- No healthy volunteers
- 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, Guangdong, 510000
About this study
Official title: A Comparative Study on the Accuracy and Safety of Robotic-Assisted Versus Endoscopic-Assisted Sentinel Lymph Node Biopsy in Patients With Breast Cancer
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 quality of life assessed by the Functional Assessment of Cancer Therapy - Breast + 4 (FACT B+4) questionnaire; 3.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, sentinel lymph node biopsy, Robotic-Assisted Surgery, Endoscopic-Assisted Surgery, accuracy, safety
- 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-SLNB | Participants with breast cancer who underwent robotic-assisted sentinel lymph node biopsy | |
| E-SLNB | Participants with breast cancer who underwent endoscopic-assisted sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy Outcomes
Sentinel lymph node biopsy (SLNB) accuracy is comprehensively evaluated in patients undergoing robotic-assisted or endoscopic-assisted SLNB for breast cancer. The following accuracy metrics are assessed: (1) false-negative rate (calculated among patients with confirmed axillary lymph node metastasis, defined as the proportion of SLNB-negative patients who have positive non-sentinel nodes on completion axillary lymph node dissection); (2) sensitivity (the proportion of patients with axillary metastasis who have a positive SLNB); (3) specificity (the proportion of patients without axillary metastasis who have a negative SLNB); (4) negative predictive value (NPV); and (5) positive predictive value (PPV).
Measured: Perioperative, at final pathology after completion axillary lymph node dissection
Secondary outcomes (9)
Sentinel Lymph Node Detection Rate
The sentinel lymph node (SLN) detection rate is defined as the percentage of patients in whom at least one SLN is successfully identified and pathologically confirmed as lymph node tissue. SLN localization is performed using indocyanine green (ICG) or carbon nanoparticle tracing. The detection rate is compared between the robotic-assisted and endoscopic-assisted SLNB groups.
Measured: Perioperative, at final pathology
Number of Sentinel Lymph Nodes Identified Per Patient
The number of sentinel lymph nodes (SLNs) identified per patient is recorded intraoperatively and confirmed by postoperative pathology as lymph node tissue. SLN localization is performed using indocyanine green (ICG) or carbon nanoparticle tracing. The mean number of SLNs identified per patient is compared between the robotic-assisted and endoscopic-assisted SLNB groups.
Measured: Perioperative, at final pathology
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 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 is 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 sentinel lymph node biopsy groups.
Measured: Intraoperative
Intraoperative Blood Loss
Intraoperative Blood Loss(mL) is compared between the robotic-assisted and endoscopic-assisted sentinel lymph node biopsy groups.
Measured: Intraoperative
Length of hospital stay
Length of hospital stay (days) is compared between the robotic-assisted and endoscopic-assisted groups.
Measured: Perioperative
Duration of postoperative drainage
Duration of postoperative drainage (days) is compared between the robotic-assisted and endoscopic-assisted groups.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Oct 2021
- Primary completion31 Oct 2025
- Study completion31 Oct 2029 (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
- 150 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
- NCT07741734
- Sponsor's protocol ID
- 366A01
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 3 Aug 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Accuracy and Safety of Robotic-Assisted Versus Endoscopic-Assisted Sentinel Lymph Node Biopsy in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT07741734
- Acronym / sponsor ID
- 366A01
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, sentinel lymph node biopsy, Robotic-Assisted Surgery, Endoscopic-Assisted Surgery, accuracy, safety
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 3 Aug 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 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 quality of life assessed by the Functional Assessment of Cancer Therapy - Breast + 4 (FACT B+4) questionnaire; 3.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-SLNB | – | –Participants with breast cancer who underwent robotic-assisted sentinel lymph node biopsy |
| E-SLNB | – | –Participants with breast cancer who underwent endoscopic-assisted sentinel lymph node biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
Accuracy Outcomes
Time frame: Perioperative, at final pathology after completion axillary lymph node dissection
Sentinel lymph node biopsy (SLNB) accuracy is comprehensively evaluated in patients undergoing robotic-assisted or endoscopic-assisted SLNB for breast cancer. The following accuracy metrics are assessed: (1) false-negative rate (calculated among patients with confirmed axillary lymph node metastasis, defined as the proportion of SLNB-negative patients who have positive non-sentinel nodes on completion axillary lymph node dissection); (2) sensitivity (the proportion of patients with axillary metastasis who have a positive SLNB); (3) specificity (the proportion of patients without axillary metastasis who have a negative SLNB); (4) negative predictive value (NPV); and (5) positive predictive value (PPV).
9 secondary outcomes
Sentinel Lymph Node Detection Rate
Time frame: Perioperative, at final pathology
Number of Sentinel Lymph Nodes Identified Per Patient
Time frame: Perioperative, at final pathology
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: Intraoperative
Intraoperative Blood Loss
Time frame: Intraoperative
Length of hospital stay
Time frame: Perioperative
Duration of postoperative drainage
Time frame: Perioperative
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 3 Aug 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.
1 site 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 1 site 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 5 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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Accuracy Outcomes (time frame: Perioperative, at final pathology after completion axillary lymph node dissection). 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 3 Aug 2026.