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NCT Number: NCT07741734

Robotic-Assisted vs. Endoscopic-Assisted Sentinel Lymph Node Biopsy in 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. Sentinel Lymph Node Detection Rate

    Time frame: Perioperative, at final pathology

    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.

  2. Number of Sentinel Lymph Nodes Identified Per Patient

    Time frame: Perioperative, at final pathology

    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.

  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 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 is compared between the two groups.

  6. Operative Time

    Time frame: Intraoperative

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

  7. Intraoperative Blood Loss

    Time frame: Intraoperative

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

  8. Length of hospital stay

    Time frame: Perioperative

    Length of hospital stay (days) is compared between the robotic-assisted and endoscopic-assisted groups.

  9. Duration of postoperative drainage

    Time frame: Perioperative

    Duration of postoperative drainage (days) is 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 Comparative Study on the Accuracy and Safety of Robotic-Assisted Versus Endoscopic-Assisted Sentinel Lymph Node Biopsy in Patients With Breast Cancer

Important dates

Study start
2021
Primary completion
2025
Study completion
2029
First posted
Aug 3, 2026
Registry last updated
Aug 3, 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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