Clinical Practice Guidelines for Visualized Percutaneous Breast Tissue Clips: Chinese Society of Breast Surgery (CSBrS) Practice Guideline 2021

Breast tissue clips, as ultrasound (US), mammogram (MMG), and magnetic resonance imaging (MRI)-visible markers, play a critical role in the precise localization of breast lesions and axillary lymph nodes (LNs) during diagnostic and therapeutic procedures. The Chinese Society of Breast Surgery (CSBrS) developed this guideline to standardize the clinical application of breast tissue clips, addressing key issues such as indications, contraindications, placement techniques, and perioperative management. The recommendations were formulated using the GRADE system, integrating evidence from clinical studies and expert consensus.

Indications for Tissue Clip Placement

Primary Breast Lesions

1. Non-palpable Suspicious Breast Lesions Requiring Surgical Biopsy
   Tissue clip placement is strongly recommended (Strength: A) for non-palpable suspicious breast lesions identified during screening. These lesions, often detected via imaging, require accurate marking to guide subsequent surgical biopsy. Studies demonstrate that clip placement under US guidance improves localization accuracy, reduces procedural time, and minimizes the risk of missing the target during excision. Retrospective data show that clips facilitate follow-up imaging and reduce re-biopsy rates by 15–20% in cases of ambiguous pathology.

2. Non-palpable Breast Cancer Planned for Breast-Conserving Surgery (BCS)
   For non-palpable breast cancer, clip placement is essential to ensure precise tumor localization during BCS. Evidence indicates that clips combined with perioperative localization techniques (e.g., guide wires or dyes) increase negative margin rates to 90% and reduce secondary resection rates by 30–40%. A meta-analysis of 12 studies confirmed that clip use lowers 5-year local recurrence rates (3.2% vs. 7.1% in non-clipped cases).

3. Breast Cancer Undergoing Neoadjuvant Therapy (NAT) and Planned for BCS
   In patients receiving NAT, clip placement before treatment initiation is critical for identifying residual tumors. Up to 57% of patients achieve clinical complete remission post-NAT, making clip-guided localization vital for surgical planning. Retrospective analyses reveal that clipped lesions have a 95% success rate in intraoperative identification, compared to 70–80% for non-clipped lesions. Clips also correlate with a 5-year local recurrence rate reduction from 8.5% to 4.3%.

Axillary Lymph Nodes

1. Metastatic Axillary Lymph Nodes (pN1) Before Neoadjuvant Therapy
   Clipping pathologically confirmed metastatic axillary LNs prior to NAT enables targeted axillary dissection (TAD), a technique combining sentinel LN biopsy and clipped LN excision. Clinical trials (ACOSOG Z1071, MARI, ILINA) report false-negative rates (FNR) of 2–7% with TAD, significantly lower than sentinel LN biopsy alone (12.6%). This approach reduces unnecessary axillary LN dissections by 40%, lowering rates of postoperative lymphedema (5% vs. 25% in traditional dissection).

Contraindications for Tissue Clip Placement

The guideline outlines absolute contraindications based on patient safety and procedural feasibility:

1. Severe Systemic Disease or Psychiatric Disorders
   Patients with uncontrolled comorbidities (e.g., cardiac failure, advanced diabetes) or psychiatric conditions impairing cooperation are excluded.
2. Bleeding or Coagulation Disorders
   Clip placement is contraindicated in patients with platelet counts 1.5 due to hemorrhage risks.
3. Local Infection or Adjacent Breast Prosthesis
   Active infection near the lesion or proximity to breast implants increases complication risks, including clip migration or infection dissemination.

Clinical Considerations for Clip Positioning

Number and Placement Techniques

• Primary Lesions and Axillary LNs
  One clip per lesion or LN is recommended to balance cost and accuracy. Multi-clip placement offers no significant advantage but increases healthcare costs by 20–30%.
• Imaging Guidance
  US-guided placement is preferred for real-time visualization and higher accuracy (95% success rate vs. 85% for MMG-guided). MMG remains an alternative for microcalcifications not visible on US.

Preoperative Localization Methods

1. Guide Wire Localization
   Widely used for its simplicity, guide wires achieve 90–95% success in excising clipped lesions. However, wire displacement occurs in 5–10% of cases, necessitating intraoperative verification.
2. Dye Localization
   Methylene blue or patent blue injections provide visual guidance but require precise timing (within 1 hour of surgery) to prevent diffusion.
3. Isotopic Tracers
   Radioactive seed localization (RSL) or technetium-99m-labeled colloid offers high accuracy (98%) but is limited by cost and radiation safety regulations.

Intraoperative Confirmation

Intraoperative radiography or specimen US is mandatory to confirm clip excision. Studies report a 5–20% clip loss rate during NAT, emphasizing the need for imaging verification to avoid incomplete resection.

Timing of Clip Placement in Neoadjuvant Therapy

Clips must be placed before NAT initiation after pathological confirmation of malignancy. Delayed placement after 2 cycles of NAT, though explored for cost-effectiveness, lacks robust evidence and risks missing the tumor bed due to rapid response. For axillary LNs, pre-NAT clipping ensures reliable post-treatment identification.

Technical and Economic Considerations

The guideline emphasizes cost-effectiveness, particularly in resource-limited settings. Single-clip placement under US guidance minimizes expenses while maintaining efficacy. Intraoperative radiography, though adding $150–200 per procedure, prevents reoperation costs ($5,000–10,000 per case).

Limitations and Future Directions

Current evidence relies heavily on retrospective studies, necessitating prospective trials to validate long-term outcomes. Innovations like bioabsorbable clips and MRI-visible markers may further enhance precision. Additionally, standardized training programs are needed to reduce operator-dependent variability in clip placement.

Conclusion

The CSBrS guidelines provide a comprehensive framework for breast tissue clip utilization, emphasizing their role in improving surgical accuracy, reducing recurrence, and optimizing patient outcomes. Adherence to these recommendations ensures standardized practices across breast care centers, particularly in managing complex cases involving neoadjuvant therapy or non-palpable lesions.

doi.org/10.1097/CM9.0000000000001585

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