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

NCT07741734 | Active Not Recruiting

• 1 other identifier: 366A01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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).

  Perioperative, at final pathology after completion axillary lymph node dissection

Secondary Outcomes (9)

• Sentinel Lymph Node Detection Rate

  Perioperative, at final pathology

• Number of Sentinel Lymph Nodes Identified Per Patient

  Perioperative, at final pathology

• 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-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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (1)

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: July 21, 2026
• First Posted: August 3, 2026
• Study Start: October 1, 2021
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)