Cited 21 times in
No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial
DC Field | Value | Language |
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dc.contributor.author | 박세호 | - |
dc.contributor.author | 정준 | - |
dc.date.accessioned | 2022-12-22T01:25:41Z | - |
dc.date.available | 2022-12-22T01:25:41Z | - |
dc.date.issued | 2022-02 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/191213 | - |
dc.description.abstract | Background: Following sentinel lymph node biopsy (SLNB), the axillary recurrence rate is very low although SLNB has a false-negative rate of 5-10%. In the ACOSOG Z0011 trial, non-sentinel positive-lymph nodes were found in more than 20% of the axillary dissection group; the SLNB only group did not have a higher axillary recurrence rate. These findings raised questions about the direct therapeutic effect of the SLNB. SLNB has post-surgical complications including lymphedema. Considering advances in imaging modalities and adjuvant therapies, the role of SLNB in early breast cancer needs to be re-evaluated. Methods: The NAUTILUS trial is a prospective multicenter randomized controlled trial involving clinical stage T1-2 and N0 breast cancer patients receiving breast-conserving surgery. Axillary ultrasound is mandatory before surgery with predefined imaging criteria for inclusion. Ultrasound-guided core needle biopsy or needle aspiration of a suspicious node is allowed. Patients will be randomized (1:1) into the no-SLNB (test) and SLNB (control) groups. A total of 1734 patients are needed, considering a 5% non-inferiority margin, 5% significance level, 80% statistical power, and 10% dropout rate. All patients in the two groups will receive ipsilateral whole-breast radiation according to a predefined protocol. The primary endpoint of this trial is the 5-year invasive disease-free survival. The secondary endpoints are overall survival, distant metastasis-free survival, axillary recurrence rate, and quality of life of the patients. Discussion: This trial will provide important evidence on the oncological safety of the omission of SLNB for early breast cancer patients undergoing breast-conserving surgery and receiving whole-breast radiation, especially when the axillary lymph node is not suspicious during preoperative axillary ultrasound. Trial registration: ClinicalTrials.gov, NCT04303715 . Registered on March 11, 2020. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | BioMed Central | - |
dc.relation.isPartOf | BMC CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Axilla / diagnostic imaging | - |
dc.subject.MESH | Axilla / pathology | - |
dc.subject.MESH | Breast Neoplasms / diagnostic imaging* | - |
dc.subject.MESH | Breast Neoplasms / pathology | - |
dc.subject.MESH | Breast Neoplasms / surgery | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lymph Node Excision* | - |
dc.subject.MESH | Lymph Nodes / diagnostic imaging | - |
dc.subject.MESH | Lymph Nodes / pathology | - |
dc.subject.MESH | Lymphatic Metastasis / diagnostic imaging* | - |
dc.subject.MESH | Mastectomy, Segmental | - |
dc.subject.MESH | Patient Selection | - |
dc.subject.MESH | Prospective Studies | - |
dc.subject.MESH | Randomized Controlled Trials as Topic | - |
dc.subject.MESH | Sentinel Lymph Node Biopsy / statistics & numerical data* | - |
dc.subject.MESH | Ultrasonography* | - |
dc.subject.MESH | Young Adult | - |
dc.title | No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Surgery (외과학교실) | - |
dc.contributor.googleauthor | Ji Gwang Jung | - |
dc.contributor.googleauthor | Se Hyun Ahn | - |
dc.contributor.googleauthor | Seeyoun Lee | - |
dc.contributor.googleauthor | Eun-Kyu Kim | - |
dc.contributor.googleauthor | Jai Min Ryu | - |
dc.contributor.googleauthor | Seho Park | - |
dc.contributor.googleauthor | Woosung Lim | - |
dc.contributor.googleauthor | Yong Sik Jung | - |
dc.contributor.googleauthor | Il Yong Chung | - |
dc.contributor.googleauthor | Joon Jeong | - |
dc.contributor.googleauthor | Ji Hyun Chang | - |
dc.contributor.googleauthor | Kyung Hwan Shin | - |
dc.contributor.googleauthor | Jung Min Chang | - |
dc.contributor.googleauthor | Woo Kyung Moon | - |
dc.contributor.googleauthor | Wonshik Han | - |
dc.identifier.doi | 10.1186/s12885-022-09273-1 | - |
dc.contributor.localId | A01524 | - |
dc.contributor.localId | A03727 | - |
dc.relation.journalcode | J00351 | - |
dc.identifier.eissn | 1471-2407 | - |
dc.identifier.pmid | 35184724 | - |
dc.subject.keyword | Breast cancer | - |
dc.subject.keyword | Sentinel node biopsy | - |
dc.subject.keyword | Ultrasound | - |
dc.contributor.alternativeName | Park, Se Ho | - |
dc.contributor.affiliatedAuthor | 박세호 | - |
dc.contributor.affiliatedAuthor | 정준 | - |
dc.citation.volume | 22 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 189 | - |
dc.identifier.bibliographicCitation | BMC CANCER, Vol.22(1) : 189, 2022-02 | - |
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