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)

유태경; 강영준; 정준; 송정윤; 강선희; 이혜윤; 김의태; 이온복; 이한별; 최수정; 박형석; 곽금희; 김재일; 김민균; 이지연; 강희준; 채병주

doi:10.4048/jbc.2021.24.e51

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자료유형: 학술저널

저자정보: 유태경 (Department of Surgery Seoul St. Mary’s Hospital College of Medicine The Catholic University of Ko) 강영준 (Department of Surgery Incheon St. Mary’s Hospital College of Medicine The Catholic University of Ko) 정준 (연세대학교) 송정윤 (경희대학교) 강선희 (계명대학교) 이혜윤 (고려대학교) 김의태 (단국대학교) 이온복 (Department of Surgery Dongnam Institute of Radiological and Medical Science Busan Korea.) 이한별 (서울대학교병원) 최수정 (Department of Surgery Seoul Medical Center Seoul Korea) 박형석 (Department of Surgery Yonsei University College of Medicine Seoul Korea.) 곽금희 (Department of Surgery Inje University Sanggye Paik Hospital Seoul Korea) 김재일 (Department of Surgery Ilsan Paik Hospital Inje University College of Medicine Goyang Korea.) 김민균 (중앙대학교) 이지연 (경북대학교) 강희준 (한림대학교) 채병주 (삼성서울병원)

저널정보: 한국유방암학회 Journal of Breast Cancer Journal of Breast Cancer Vol.24 No.6

발행연도: 2021.12

수록면: 569 - 577 (9page)

DOI: 10.4048/jbc.2021.24.e51

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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. Trial Registration ClinicalTrials.gov Identifier: NCT03975179; Clinical Research Information Service Identifier: KCT0004606

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. Trial Registration ClinicalTrials.gov Identifier: NCT03975179; Clinical Research Information Service Identifier: KCT0004606

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

참고문헌 (27)

참고문헌 신청

Meric F / 2003 / Positive surgical margins and ipsilateral breast tumor recurrence predict disease-specific survival after breast-conserving therapy / Cancer 97:926~933

Jee Yeon Lee / 2012 / Multiple Margin Positivity of Frozen Section Is an Independent Risk Factor for Local Recurrence in Breast-Conserving Surgery / Journal of Breast Cancer 15(4):420~426

Woohyun Jung / 2012 / Factors Associated with Re-excision after Breast-Conserving Surgery for Early-Stage Breast Cancer / Journal of Breast Cancer 15(4):412~419

McCahill LE / 2012 / Variability in reexcision following breast conservation surgery / JAMA 307:467~475

Morrow M / 2009 / Surgeon recommendations and receipt of mastectomy for treatment of breast cancer / JAMA 302:1551~1556

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YOO TAE KYUNG R

소속기관 Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea