%0 Journal Article
%T Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life. A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery (COBALT trial)
%A Nicole MA Krekel
%A Barbara M Zonderhuis
%A Hermien WH Schreurs
%A Alexander MF Lopes Cardozo
%A Herman Rijna
%A Henk van der Veen
%A Sandra Muller
%A Pieter Poortman
%A Louise de Widt
%A Wilfred K de Roos
%A Anne Bosch
%A Annette HM Taets van Amerongen
%A Elisabeth Bergers
%A Mecheline HM van der Linden
%A Elly SM de Lange de Klerk
%A Henri AH Winters
%A Sybren Meijer
%A Petrousjka MP van den Tol
%J BMC Surgery
%D 2011
%I BioMed Central
%R 10.1186/1471-2482-11-8
%X In this prospective multicentre randomised controlled clinical trial, 120 women who have been diagnosed with palpable early-stage (T1-2N0-1) primary invasive breast cancer and deemed suitable for breast-conserving surgery will be randomised between ultrasound-guided surgery and palpation-guided surgery. With this sample size, an expected 20% reduction of resected breast tissue and an 18% difference in tumour-free margins can be detected with a power of 80%. Secondary endpoints include cosmetic outcomes and quality of life. The rationale, study design and planned analyses are described.The COBALT trial is a prospective, multicentre, randomised controlled study to assess the efficacy of ultrasound-guided breast-conserving surgery in patients with palpable early-stage primary invasive breast cancer in terms of the sparing of breast tissue, oncological margin status, cosmetic outcomes and quality of life.Netherlands Trial Register (NTR): NTR2579Breast cancer is the most common cancer among women in the western world. It affects women of all ages and the lifetime risk of developing invasive breast cancer is 12-13%. The 5-year disease-free survival rate for node-negative breast cancer, however, is excellent (98%). Breast cancer surgery has changed dramatically over the past few decades. Breast-conserving therapy (BCT) was introduced in the 1970s and refers to the surgical removal of the breast tumour in all cases followed by radiotherapy to eradicate residual tumour cells. The introduction of the sentinel node procedure for nodal staging has avoided the morbidity of axillary lymph node dissection in the majority of patients. Several trials demonstrated comparable results with regard to disease-free and overall survival between mastectomy and BCT combined with radiotherapy, and the latter has become the standard of care for early-stage breast cancer. According to national guidelines, 75% of breast cancer patients are suitable for BCT. The main advantage of BCT over mastect
%U http://www.biomedcentral.com/1471-2482/11/8