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The INTEND 1 randomized controlled trial of duct endoscopy as an indicator of margin excision in breast conservation surgery

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Abstract

Purpose

With early detection, breast conservation surgery with adequate surgical margins is the standard of care. The aim of this study was to evaluate the use of pre-operative duct endoscopy (DE) to target surgical resection, improve adequate margins and reduce re-excision operations.

Methods

Women with DCIS, stage I and II breast cancer suitable for breast conservation were randomized to DE-assisted wide local excision versus standard wide local excision (without DE). The primary endpoint was margin re-excision rates between the two groups. Secondary end points were: (i) volume differences of the surgical specimen; (ii) whether an extensive in situ component (EIC) influenced successful DE-guided resection.

Results

78 women were randomized: 44 patients to no-DE and 34 patients to the DE group. The median age was 59 (49–65) and 56 (48–64) years in the two groups respectively with mean follow-up of 9.1 (4.2–11.1) years. There were 23 positive findings in 17 women in 30 successful DE procedures (17/30 = 56.7%). The surgical specimen volume, no-DE (17 [IQR 10–29] cm3) and DE 20 [IQR 12–28] cm3), did not differ, p = 0.377. The overall re-excision rate was 20/78 (26%), 9 (20%) and 11 (32% in the no-DE and DE groups, respectively, p = 0.233.

Conclusions

This randomized clinical trial was limited by incomplete accrual. DE did not contribute to improved margin excision rates whether a target lesion was visualized or not. The presence of EIC did not improve efficacy of DE.

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Acknowledgements

The authors acknowledge staff and colleagues at the Royal Marsden Hospital who contributed patients to this study and the theatre team who helped maintain the duct endoscopy equipment. This study was funded by grants from the National Institute for Health, Biomedical Research Centre at the Royal Marsden, the Shocking Pink Party Appeal and the Dr Susan Love Research Foundation.

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Authors and Affiliations

  1. Department of Surgery, Royal Marsden NHS Trust, London, SW3 6JJ, UK

    Gerald Gui, Effrosyni Panopoulou, Sarah Tang, Dominique Twelves, Ann Ward & Catherine Montgomery

  2. Department of Clinical Research and Development, Royal Marsden NHS Trust, London, UK

    Mohammed Kabir

  3. Department of Histopathology, Royal Marsden NHS Trust, London, UK

    Ashutosh Nerurkar & Peter Osin

  4. The Breast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK

    Clare M. Isacke

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  1. Gerald Gui
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  2. Effrosyni Panopoulou
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Correspondence to Gerald Gui.

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Gui, G., Panopoulou, E., Tang, S. et al. The INTEND 1 randomized controlled trial of duct endoscopy as an indicator of margin excision in breast conservation surgery. Breast Cancer Res Treat 186, 723–730 (2021). https://doi.org/10.1007/s10549-020-06065-8

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