Study protocol

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

Stijn van Esser¹ , Monique GG Hobbelink² , Petra HM Peeters⁴ , Erik Buskens^4,5 , Iris M van der Ploeg¹ , Willem PTHM Mali³ , Inne H M Borel Rinkes¹ and Richard van Hillegersberg¹

¹Department of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, G04.228 3584 CX Utrecht, The Netherlands

²Department of Nuclear Medicine, University medical Center Utrecht, Heidelberglaan 100, E01.132 3584 CX Utrecht, The Netherlands

³Department of Radiology, University Medical Center Utrecht, Heidelberglaan 100, E01.132 3584 CX Utrecht, The Netherlands

⁴Clinical epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, STR 6.131 3584 CX Utrecht, The Netherlands

⁵Department of Epidemiology, University Medical Center Groningen, University of Groningen, PO box 30.001, E3.018, 9700 RB, Groningen, The Netherlands

author email corresponding author email

BMC Surgery 2008, 8:9doi:10.1186/1471-2482-8-9

Published:	21 May 2008

Abstract

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/design

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.

Trial Registration

(http://www.clinicaltrials.gov webcite, study protocol number NCT00539474)