J Breast Cancer.  2021 Dec;24(6):569-577. 10.4048/jbc.2021.24.e51.

A Randomized Controlled Trial for Doing vs. Omitting Intraoperative Frozen Section Biopsy for Resection Margin Status in Selected Patients Undergoing Breast-Conserving Surgery (OFF-MAP Trial)

Affiliations
  • 1Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 2Department of Surgery, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 3Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 4Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, Korea
  • 5Department of Surgery, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, Korea
  • 6Department of Surgery, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Korea
  • 7Department of Surgery, Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea
  • 8Department of Surgery, Dongnam Institute of Radiological and Medical Science, Busan, Korea
  • 9Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
  • 10Department of Surgery, Seoul Medical Center, Seoul, Korea
  • 11Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
  • 12Department of Surgery, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea
  • 13Department of Surgery, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea
  • 14Department of Surgery, Chung-Ang University Hospital, Seoul, Korea
  • 15Department of Surgery, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, Daegu, Korea
  • 16Division of Breast and Endocrine Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea
  • 17Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Abstract

Purpose
Intraoperative frozen section biopsy is used to reduce the margin positive rate and re-excision rate and has been reported to have high diagnostic accuracy. A majority of breast surgeons in the Republic of Korea routinely perform frozen section biopsy to assess margins intraoperatively, despite its long turnaround time and high resource requirements. This study aims to determine whether omitting frozen section biopsy for intraoperative margin evaluation in selected patients is non-inferior to performing frozen section biopsy in terms of resection margin positivity rate.
Methods
This study is a phase III, randomized controlled, parallel-group, multicenter non-inferiority clinical trial. Patients meeting the inclusion criteria and providing written informed consent will be randomized to the “frozen section biopsy” or “frozen section biopsy omission” group after lumpectomy. Patients with clinical stage T1–T3 disease who are diagnosed with invasive breast cancer by core-needle biopsy and plan to undergo breast-conserving surgery will be included in this study. If a daughter nodule, non-mass enhancement, or microcalcification is identified on preoperative imaging, these features must be within 1 cm of the main mass for inclusion in the trial. The target sample size is 646 patients per arm. The primary endpoint will be the resection margin positive rate, and the secondary endpoints include the reoperation rate, operating time, residual cancer after reoperation, residual cancer after re-excision according to the frozen section biopsy result, resection volume, patient quality of life, and cost-effectiveness. Discussion: This is the first randomized clinical trial utilizing frozen section biopsy for intraoperative margin evaluation and aims to determine the non-inferiority of omitting frozen section biopsy in selected patients compared to performing frozen section biopsy. We expect that this trial will help surgeons perform the procedure more efficiently while ensuring patient safety.

Keyword

Breast Neoplasms; Frozen Sections; Margins of Excision; Mastectomy; Segmental
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