Hydrogel-Coated Clips Are Associated with a Higher Risk of Dislocation After Ultrasound-Guided Breast Biopsy
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Inclusion and Exclusion Criteria
2.3. Ultrasound Examination
2.4. Biopsy Procedure and Follow-Up Examinations
- UltraClip Dual Trigger Biodur 108 Coil Marker (UC), Becton Dickinson, Franklin Lakes, NJ, USA;
- TUMARK Professional (TP), Somatex Medical Technologies, Berlin, Germany;
- TUMARK Vision (TV), Somatex Medical Technologies, Berlin, Germany;
- HydroMARK Breast Biopsy Site Marker (HM), Mammatome, Quickborn, Germany.
2.5. Histopathologic Evaluation
2.6. Statistical Analysis
3. Results
3.1. Patient and Lesion Demographics
3.2. Dislocation/Migration Rates and Time Courses
3.3. Analysis of Cofactors of Clip Dislocation
4. Discussion
Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
| UC | UltraClip Dual Trigger Biodur 108 Coil Marker |
| TP | TUMARK Professional |
| TV | TUMARK Vision |
| HM | HydroMARK Breast Biopsy Site Marker |
| SWE | Shear Wave elastography |
| ACR | American College of Radiology |
| SE | Strain elastography |
| CNB | Core needle biopsy |
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| Inclusion Criteria | Exclusion Criteria |
|---|---|
| Ultrasound-guided biopsy for a newly diagnosed breast tumour with same-day clip confirmation mammogram | Patient age under 18 years |
| Sufficient ultrasound documentation, including B-mode and shear-wave elastography imaging | Prior history of ipsilateral breast cancer |
| Follow-up imaging, including post-biopsy mammogram and (a) at least one follow-up examination, including post-wire mammogram or (b) one follow-up examination at least 3 months apart from the initial placement. | Insufficient ultrasound documentation |
| Available histological diagnosis | Patients undergoing neoadjuvant Therapy |
| Inconclusive histology |
| Variables | n (%) |
|---|---|
| Sex | |
| Female | 346 (98.9) |
| Male | 4 (1.1) |
| Age group | |
| 18–39 | 39 (11.1) |
| 40–59 | 141 (40.3) |
| ≥60 | 170 (48.6) |
| Breast lesions localisation | |
| Left breast | 187 (53.4) |
| Right breast | 163 (46.6) |
| Upper outer quadrant | 196 (56.0) |
| Lower outer quadrant | 72 (20.6) |
| Upper inner quadrant | 38 (10.9) |
| Lower inner quadrant | 44 (12.5) |
| Overall breast density | |
| ACR A | 61 (18.9) |
| ACR B | 83 (25.7) |
| ACR C | 114 (35.3) |
| ACR D | 65 (20.1) |
| Perilesional breast density | |
| Mostly glandular tissue | 38 (10.9) |
| Mixed glandular and fatty tissue | 123 (35.1) |
| Predominantly fatty tissue | 189 (54.0) |
| Maximal lesion diameter | [mm] |
| Mean ± SD | 16.5 ± 10.8 |
| Range | 2.0 to 70.0 |
| Lesion volume | [cm3] |
| Mean ± SD | 2.2 ± 4.9 |
| range | 0.1 to 47.0 |
| Histopathological Diagnosis | n (%) |
|---|---|
| Benign lesions | 107 (30.6) |
| Fibrous-cystic mastopathy | 60 (56.1) |
| Fibroadenoma | 33 (30.8) |
| Focal mastitis/fatty necrosis | 7 (6.5) |
| other | 7 (6.5) |
| High-risk lesions | 13 (3.7) |
| Papillomatous neoplasia | 7 (53.8) |
| ADH/epithelial proliferation | 4 (30.8) |
| other | 2 (15.4) |
| Malignant lesions | 230 (65.7) |
| Invasive carcinoma, no special type (NST) | 183 (79.6) |
| Ductal carcinoma in-situ | 20 (8.7) |
| Invasive lobular carcinoma | 15 (6.5) |
| other | 12 (5.2) |
| Clip Type | Overall Clips (n) | Migration Rate (%) | Dislocation Rate (%) | Clip Displacement Distance [mm] |
|---|---|---|---|---|
| UC | 100 | 26 | 14 | 4.7 ± 4.7 mm |
| TP | 50 | 18 | 20 | 3.6 ± 3.6 mm |
| TV | 100 | 10 | 9 | 4.9 ± 2.6 mm |
| HM | 100 | 25 | 38 | 4.0 ± 4.3 mm |
| OR (95% CI) | ||||||
|---|---|---|---|---|---|---|
| Variables | b | SE | p-Value | OR | Lower Value | Upper Value |
| Predominantly fatty tissue perilesional | 1.105 | 0.553 | 0.046 | 3.020 | 1.021 | 8.932 |
| Distance Lesion—Skin [mm] | 0.007 | 0.054 | 0.901 | 1.007 | 0.905 | 1.119 |
| Distance Lesion—Pectoralis [mm] | 0.053 | 0.069 | 0.435 | 1.055 | 0.922 | 1.207 |
| Lesion volume [cm3] | 0.215 | 0.142 | 0.131 | 1.240 | 0.938 | 1.638 |
| Vascularity | ||||||
| None * | 0.177 | |||||
| Sparse | 0.922 | 1.065 | 0.386 | 2.515 | 0.312 | 20.267 |
| Moderate | −1.553 | 1.157 | 0.179 | 0.212 | 0.022 | 2.042 |
| Strong | −1.538 | 1.056 | 0.145 | 0.215 | 0.027 | 1.703 |
| Contour | ||||||
| Smooth * | 0.041 | |||||
| Lobulated | −4.335 | 1.721 | 0.012 | 0.013 | 0.000 | 0.382 |
| Irregular | −4.648 | 2.006 | 0.021 | 0.010 | 0.000 | 0.489 |
| Margin | ||||||
| Circumscribed * | 0.264 | |||||
| Partially circumscribed | −0.867 | 1.346 | 0.519 | 0.420 | 0.030 | 5.875 |
| Diffuse | 0.977 | 1.448 | 0.500 | 2.656 | 0.155 | 45.384 |
| Strain Elastography | ||||||
| Soft * | 0.001 | |||||
| Hard | 4.677 | 1.591 | 0.003 | 107.408 | 4.748 | 2429.799 |
| Same as surrounding | −1.239 | 1.631 | 0.448 | 0.290 | 0.012 | 7.082 |
| Shear wave (SWE) assessment | ||||||
| Intralesional SWE [m/s] | −0.005 | 0.030 | 0.860 | 0.995 | 0.938 | 1.055 |
| Perilesional SWE [m/s] | −0.501 | 0.260 | 0.054 | 0.606 | 0.364 | 1.008 |
| Clip type | ||||||
| UC * | 0.128 | |||||
| TP | 2.385 | 1.687 | 0.158 | 10.854 | 0.398 | 296.232 |
| TV | 2.100 | 1.575 | 0.182 | 8.170 | 0.373 | 179.095 |
| HM | 3.285 | 1.531 | 0.032 | 26.719 | 1.329 | 537.001 |
| Procedure related | ||||||
| CNB samples [n] | 0.145 | 0.487 | 0.766 | 1.156 | 0.445 | 3.006 |
| Needle gauge | −0.263 | 0.624 | 0.674 | 0.769 | 0.226 | 2.613 |
| Clip-to-lesion-surface | −0.581 | 0.185 | 0.002 | 0.559 | 0.389 | 0.803 |
| Distance [mm] | ||||||
| Perilesional hematoma (yes) | −0.816 | 0.922 | 0.376 | 0.442 | 0.073 | 2.694 |
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Share and Cite
Swoboda, M.; Deeg, J.; Panczel, M.; Amort, B.; Haushammer, S.; Ladenhauf, V.; Galijasevic, M.; Lacaita, P.G.; Egle, D.; Soleiman, A.; et al. Hydrogel-Coated Clips Are Associated with a Higher Risk of Dislocation After Ultrasound-Guided Breast Biopsy. Diagnostics 2026, 16, 1915. https://doi.org/10.3390/diagnostics16121915
Swoboda M, Deeg J, Panczel M, Amort B, Haushammer S, Ladenhauf V, Galijasevic M, Lacaita PG, Egle D, Soleiman A, et al. Hydrogel-Coated Clips Are Associated with a Higher Risk of Dislocation After Ultrasound-Guided Breast Biopsy. Diagnostics. 2026; 16(12):1915. https://doi.org/10.3390/diagnostics16121915
Chicago/Turabian StyleSwoboda, Michael, Johannes Deeg, Mark Panczel, Birgit Amort, Silke Haushammer, Valentin Ladenhauf, Malik Galijasevic, Pietro G. Lacaita, Daniel Egle, Afschin Soleiman, and et al. 2026. "Hydrogel-Coated Clips Are Associated with a Higher Risk of Dislocation After Ultrasound-Guided Breast Biopsy" Diagnostics 16, no. 12: 1915. https://doi.org/10.3390/diagnostics16121915
APA StyleSwoboda, M., Deeg, J., Panczel, M., Amort, B., Haushammer, S., Ladenhauf, V., Galijasevic, M., Lacaita, P. G., Egle, D., Soleiman, A., Kluckner, M., & Gruber, L. (2026). Hydrogel-Coated Clips Are Associated with a Higher Risk of Dislocation After Ultrasound-Guided Breast Biopsy. Diagnostics, 16(12), 1915. https://doi.org/10.3390/diagnostics16121915

