The efficacy of 'radio guided occult lesion localization' (ROLL) versus 'wire-guided localization' (WGL) in breast conserving surgery for non-palpable breast cancer: a randomized clinical trial - ROLL study.
BACKGROUND
With the increasing number of non palpable breast carcinomas, the need of a good and reliable localization method increases. Currently the wire guided localization (WGL) is the standard of care in most countries. Radio guided occult lesion localization (ROLL) is a new technique that may improve the oncological outcome, cost effectiveness, patient comfort and cosmetic outcome. However, the studies published hitherto are of poor quality providing less than convincing evidence to change the current standard of care. The aim of this study is to compare the ROLL technique with the standard of care (WGL) regarding the percentage of tumour free margins, cost effectiveness, patient comfort and cosmetic outcome.


METHODS
The ROLL trial is a multi center randomized clinical trial. Over a period of 2-3 years 316 patients will be randomized between the ROLL and the WGL technique. With this number, the expected 15% difference in tumour free margins can be detected with a power of 80%. Other endpoints include cosmetic outcome, cost effectiveness, patient (dis)comfort, degree of difficulty of the procedures and the success rate of the sentinel node procedure. The rationale, study design and planned analyses are described.


BACKGROUND
(http://www.clinicaltrials.gov, study protocol number NCT00539474).
van Esser
Stijn
S
Department of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, G04,228 3584 CX Utrecht, The Netherlands. s.vanesser@umcutrecht.nl
Hobbelink
Monique G G
MG
Peeters
Petra H M
PH
Buskens
Erik
E
van der Ploeg
Iris M
IM
Mali
Willem P T H M
WP
Rinkes
Inne H M Borel
IH
van Hillegersberg
Richard
R
D001943:Breast Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental / Q000379:methods*; D017063:Outcome Assessment, Health Care; D011849:Radioactive Tracers; D019275:Radiopharmaceuticals; D012107:Research Design
D011849:Radioactive Tracers; D019275:Radiopharmaceuticals