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Prospective clinical trial on the learning curve of high-intensity-focused ultrasound for the treatment of breast fibroadenoma

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Abstract

Introduction

High-intensity-focused ultrasound (HIFU) is a safe and feasible treatment option for breast fibroadenoma. However, its learning curve has not been described in the medical literature.

Methods

All patients with biopsy-proven fibroadenoma considered indicated for HIFU were screened for eligibility for HIFU treatment. A total of 60 patients were recruited according to the pre-defined sample size calculation.

Results

Sixty consecutive patients were divided into three cohorts in chronological order. The mean tumor volume shrinkage rates in cohorts 1, 2, and 3 at 6 months post-HIFU ablation were 38%, 34%, and 59%, respectively. Significant tumor shrinkage was observed from case 41 onward (p < 0.0001). Similarly, the mean tumor volume shrinkage rates in cohorts 1, 2, and 3 at 12 months post-HIFU ablation were 45%, 51%, and 71%, respectively. Significant tumor shrinkage was observed from case 41 onwards (p < 0.0473). The mean procedure time for the first 20 patients was 48.5 (range 45–75) minutes, while that in the second 20 patients was 39.7 (range 20–60) minutes, and that in the last 20 patients was 28.9 (range 15–45) minutes. The treatment time was significantly shorter from case 41 onwards (p = 0.0481).

Conclusion

Treatment outcomes and treatment time improved significantly after performing approximately 40 HIFU procedures.

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Data availability

Study data are available upon request from the corresponding author.

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Acknowledgements

This study received support of consumables from Theraclion.

Funding

This study is funded by The University of Hong Kong Seed Fund Grant Number: 201606159012.

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Author notes

  1. Michael Co is first author.

Authors and Affiliations

  1. Department of Surgery, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China

    Michael Co, Clement Chen, Cassandra Lee, Stephanie Yu & Ava Kwong

Authors
  1. Michael Co
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  2. Clement Chen
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  3. Cassandra Lee
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  4. Stephanie Yu
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  5. Ava Kwong
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Corresponding author

Correspondence to Ava Kwong.

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Conflict of interest

Theraclion supported consumables for the research study.

Ethical approval

Ethical approval has been obtained from Institutional Review Board of Hong Kong Hospital Authority West Cluster.

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Co, M., Chen, C., Lee, C. et al. Prospective clinical trial on the learning curve of high-intensity-focused ultrasound for the treatment of breast fibroadenoma. Surg Today 52, 1048–1053 (2022). https://doi.org/10.1007/s00595-021-02421-3

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  • DOI: https://doi.org/10.1007/s00595-021-02421-3

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