ROLLIS roll‐out: Pitfalls, errors, lessons learned and recommendations from Australian and New Zealand experience during the randomised controlled trial, implementing a novel localisation method for impalpable malignant breast lesions, radio‐guided occult lesion localisation with iodine‐125 ((125)I) seed (ROLLIS)

INTRODUCTION: Breast cancer surgery aims to excise lesions with clear margins and provide optimal cosmesis with a low re‐excision rates. These aims are aided by accurate lesion localisation and a surgical choice of incision site with minimal removal of healthy tissue. Problems associated with hookwires have led to adoption of non‐wire methods including radioguided occult lesion localisation using iodine‐125 (ROLLIS). This paper outlines the problems encountered and lessons learnt during the largest RCT involving 659 participants, conducted at eight sites (seven Australian, one New Zealand centres) between September 2013 and April 2018.* METHODS: Data, along with substantive comments, regarding each ROLLIS procedure, documenting each step from the seed insertion, ease of operative retrieval, to return of the seed to medical physics, from a shared on‐line secure database and a separate site email survey, were synthesised and categorised. RESULTS: The Australian and New Zealand ROLLIS RCT experience highlights several important issues. Lessons learned were related to licencing the seed and tracking protocols. A Designated Team Lead, who is a good communicator, ensuring the Tracking Protocols were accurately followed and updated, subspecialty leads and a Co‐ordinator, responsible for training, logbook maintenance and seed ordering, enhanced the success and acceptance of the programme. Addressing radiation issues, fears, education of staff and seed loss was imperative. CONCLUSION: The Australian and New Zealand ROLLIS RCT experience highlights the need for adherence to local licencing laws and protocols, appointing a dedicated ROLLIS Designated Team Lead with good communication and a ROLLIS Co‐ordinator. These facilitate the adoption of a successful ROLLIS programme.