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

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• 作者：Stijn van Esser (1)
  Monique GG Hobbelink (2)
  Petra HM Peeters (4)
  Erik Buskens (4) (5)
  Iris M van der Ploeg (1)
  Willem PTHM Mali (3)
  Inne H M Borel Rinkes (1)
  Richard van Hillegersberg (1)
  
• 刊名：BMC Surgery
• 出版年：2008
• 出版时间：December 2008
• 年：2008
• 卷：8
• 期：1
• 全文大小：499KB
• 参考文献：1. De Cicco C, Pizzamiglio M, Trifiro G, Luini A, Ferrari M, Prisco G, Galimberti V, Cassano E, Viale G, Intra M, Veronesi P, Paganelli G: Radioguided occult lesion localisation (ROLL) and surgical biopsy in breast cancer. Technical aspects. / Q J Nucl Med 2002, 46:145-51.
  2. Nadeem R, Chagla LS, Harris O, Desmond S, Thind R, Titterrell C, Audisio RA: Occult breast lesions: A comparison between radioguided occult lesion localisation (ROLL) vs. wire-guided lumpectomy (WGL). / Breast 2005, 14:283-89. CrossRef
  3. Rahusen FD, Bremers AJ, Fabry HF, van Amerongen AH, Boom RP, Meijer S: Ultrasound-guided lumpectomy of nonpalpable breast cancer versus wire-guided resection: a randomized clinical trial. / Ann Surg Oncol 2002, 9:994-98. CrossRef
  4. Luini A, Zurrida S, Galimberti V, Paganelli G: Radioguided surgery of occult breast lesions. / Eur J Cancer 1998, 34:204-05. CrossRef
  5. Ploeg I, Hobbelink M, Bosch MA, Mali WP, Rinkes IH, van Hillegersberg R: 'Radioguided occult lesion localisation' (ROLL) for non-palpable breast lesions: A review of the relevant literature. / Eur J Surg Oncol 2007.
  6. Rampaul RS, Bagnall M, Burrell H, Pinder SE, Evans AJ, Macmillan RD: Randomized clinical trial comparing radioisotope occult lesion localization and wire-guided excision for biopsy of occult breast lesions. / Br J Surg 2004, 91:1575-577. CrossRef
  7. Thind CR, Desmond S, Harris O, Nadeem R, Chagla LS, Audisio RA: Radio-guided localization of clinically occult breast lesions (ROLL): a DGH experience. / Clin Radiol 2005, 60:681-86. CrossRef
  8. Luini A, Zurrida S, Paganelli G, Galimberti V, Sacchini V, Monti S, Veronesi P, Viale G, Veronesi U: Comparison of radioguided excision with wire localization of occult breast lesions. / Br J Surg 1999, 86:522-25. CrossRef
  9. Nadeem R, Chagla LS, Harris O, Desmond S, Thind R, Titterrell C, Audisio RA: Occult breast lesions: A comparison between radioguided occult lesion localisation (ROLL) vs. wire-guided lumpectomy (WGL). / Breast 2005, 14:283-89. CrossRef
  10. Rampaul RS, Bagnall M, Burrell H, Pinder SE, Evans AJ, Macmillan RD: Randomized clinical trial comparing radioisotope occult lesion localization and wire-guided excision for biopsy of occult breast lesions. / Br J Surg 2004, 91:1575-577. CrossRef
  11. Ronka R, Krogerus L, Leppanen E, von Smitten K, Leidenius M: Radio-guided occult lesion localization in patients undergoing breast-conserving surgery and sentinel node biopsy. / Am J Surg 2004, 187:491-96. CrossRef
  12. Tanis PJ, Deurloo EE, Valdes Olmos RA, Rutgers EJ, Nieweg OE, Besnard AP, Kroon BB: Single intralesional tracer dose for radio-guided excision of clinically occult breast cancer and sentinel node. / Ann Surg Oncol 2001, 8:850-55. CrossRef
  13. Thind CR, Desmond S, Harris O, Nadeem R, Chagla LS, Audisio RA: Radio-guided localization of clinically occult breast lesions (ROLL): a DGH experience. / Clin Radiol 2005, 60:681-86. CrossRef
  14. Zgajnar J, Hocevar M, Frkovic-Grazio S, Hertl K, Schweiger E, Besic N: Radioguided occult lesion localization (ROLL) of the nonpalpable breast lesions. / Neoplasma 2004, 51:385-89.
  15. Thind CR, Desmond S, Harris O, Nadeem R, Chagla LS, Audisio RA: Radio-guided localization of clinically occult breast lesions (ROLL): a DGH experience. / Clin Radiol 2005, 60:681-86. CrossRef
  16. Rampaul RS, Bagnall M, Burrell H, Pinder SE, Evans AJ, Macmillan RD: Randomized clinical trial comparing radioisotope occult lesion localization and wire-guided excision for biopsy of occult breast lesions. / Br J Surg 2004, 91:1575-577. CrossRef
  17. van Rijk MC, Tanis PJ, Nieweg OE, Loo CE, Olmos RA, Oldenburg HS, Rutgers EJ, Hoefnagel CA, Kroon BB: Sentinel node biopsy and concomitant probe-guided tumour excision of nonpalpable breast cancer. / Ann Surg Oncol 2007, 14:627-32. CrossRef
  18. Barros AC, Barros MA, Andrade FE, Mori LJ, Costa PA, Sheng PY, Pelizon CH: Combined radioguided nonpalpable lesion localization and sentinel lymph node biopsy for early breast carcinoma. / Ann Surg Oncol 2007, 14:1472-477. CrossRef
  19. Medina-Franco H, barca-Perez L, Ulloa-Gomez JL, Romero C: Radioguided localization of clinically occult breast lesions (ROLL): a pilot study. / Breast J 2007, 13:401-05. CrossRef
  20. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2482/8/9/prepub
  
• 作者单位：Stijn van Esser (1)
  Monique GG Hobbelink (2)
  Petra HM Peeters (4)
  Erik Buskens (4) (5)
  Iris M van der Ploeg (1)
  Willem PTHM Mali (3)
  Inne H M Borel Rinkes (1)
  Richard van Hillegersberg (1)
  
  1. Department of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, G04.228 3584 CX, Utrecht, The Netherlands
  2. Department of Nuclear Medicine, University medical Center Utrecht, Heidelberglaan 100, E01.132 3584 CX, Utrecht, The Netherlands
  4. Clinical epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, STR 6.131 3584 CX, Utrecht, The Netherlands
  5. Department of Epidemiology, University Medical Center Groningen, University of Groningen, PO box 30.001, E3.018, 9700 RB, Groningen, The Netherlands
  3. Department of Radiology, University Medical Center Utrecht, Heidelberglaan 100, E01.132 3584 CX, Utrecht, The Netherlands
  

文摘

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- 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, study protocol number NCT00539474)