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临床试验/NCT07519668
NCT07519668已完成不适用

Retrospective Evaluation of the R1/ Post-resection Rate With Intraoperative Measurement of the Target Volume Using Ultrasound by a Surgeon (Ultrasound-assisted Tumor Surgery) as Part of Breast-conserving Therapy in Breast Cancer

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 273 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
273
试验地点
1
主要终点
R1 resection rates

研究概览

简要总结

The aim of this study is to evaluate whether standardizing intraoperative ultrasound (IOUS) with the "Tübingen Ultrasound Ruler" reduces R1 resection rates in breast-conserving surgery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age at least 18 years and no more than 80 years (inclusive)
  • Preoperatively histologically confirmed breast cancer, detectable by ultrasound
  • Unifocal to multifocal findings
  • Palpable and/or non-palpable findings
  • Indication for breast-conserving therapy (BCT)

排除标准

  • Sonographically ambiguous findings
  • Multicentricity
  • Exclusion criteria for BCT
  • Status after neoadjuvant chemotherapy

研究组 & 干预措施

Uni- or Bilateral Ductal Carcinoma in Situ (DCIS) or Invasive Breast Cancer

This retrospective, single-center study included 313 surgical procedures performed on 304 patients between January 2020 and December 2023. The patients underwent breast-conserving surgery (BCS) for unilateral or bilateral ductal carcinoma in situ (DCIS) or invasive breast cancer. All surgeries were performed by a single surgeon.

结局指标

主要结局

R1 resection rates

时间窗: 3 years

In this retrospective study, R1 resections were defined as cases requiring a follow-up surgery due to incomplete tumor removal.

次要结局

  • Weight of main specimen(Day of excision)
  • Duration of surgery(During surgery)
  • Number of Shavings(During surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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