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04.01.2021 | Clinical trial

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

verfasst von: Gerald Gui, Effrosyni Panopoulou, Sarah Tang, Dominique Twelves, Mohammed Kabir, Ann Ward, Catherine Montgomery, Ashutosh Nerurkar, Peter Osin, Clare M. Isacke

Erschienen in: Breast Cancer Research and Treatment | Ausgabe 3/2021

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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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Titel: The INTEND 1 randomized controlled trial of duct endoscopy as an indicator of margin excision in breast conservation surgery
verfasst von: Gerald Gui
Effrosyni Panopoulou
Sarah Tang
Dominique Twelves
Mohammed Kabir
Ann Ward
Catherine Montgomery
Ashutosh Nerurkar
Peter Osin
Clare M. Isacke
Publikationsdatum: 04.01.2021
Verlag: Springer US
Erschienen in: Breast Cancer Research and Treatment / Ausgabe 3/2021
Print ISSN: 0167-6806
Elektronische ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-020-06065-8

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