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临床试验/NCT05708664
NCT05708664已完成不适用

Precision Breast Conserving Surgery With the Guidance of Localization Combined With Multidetector CT 3-dimensional Image Reconstruction: a Single Center, Prospective, Cohort Study.

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
The sum of located margin resection widths

研究概览

简要总结

From 2021 to 2022, 31 patients with unifocal breast cancer were enrolled for precision breast conserving surgery (PBCS) guided by wire guided localization (WGL) combined with CT guided 3D reconstruction. Surrounded WGL was performed under local anesthesia, followed by an immediate contrast enhanced CT scan. PBCS guided by CT guided 3D reconstruction was performed one day after the localization. Women who underwent palpation guided breast conserving surgery (BCS) were included as control. Two-sided Student t test, Fisher's exact test and chi-square test was applied.

详细描述

Background Breast conserving surgery (BCS) with radiation is accepted as a standard local treatment for early-stage breast cancer. This is largely based on the results of NSABP B-06 trial, demonstrating no significant difference in survival among patients who received total mastectomy or lumpectomy [1]. More recent studies showed that the overall survival was superior for BCS compared with mastectomy [2,3,4]. Furthermore, long-term quality of life (QoL) was better in patients treated with BCS than with mastectomy [5]. Advantages in survival and QoL have led to a higher demand for BCS.

Success of BCS is characterized by negative margins and a good cosmetic outcome. This requires doctors to precisely remove the tumor while preserving as much normal tissue as possible. Current guidelines strongly recommend achieving "no ink on tumor" for invasive breast cancer (IBC) . More widely clear margins do not significantly decrease the rate of ipsilateral breast cancer recurrence (IBCR) [6]. However, conventional localization techniques only provide approximate tumor center and fail to provide tumor extents [7]. In clinical practice, doctors may remove more tissue to achieve negative margins and avoid a reoperative intervention. Among the patients treating with BCS, 30% survivals were dissatisfied with the cosmetic outcome [8].

Wire-guided localization (WGL) is a feasible, widely used technology used for the localization of nonpalpable breast lesions prior to surgical management. The flexible self-retaining wire can be inserted into the exact lesion guided by ultrasound (US) or mammography. The surgeon than uses the wire as a guide to excise the lesion [9]. At the same time, the metal needle is visible under CT. The role of multidetector CT (MDCT) is limited in the diagnosis of breast tumors [10,11]. However, MDCT has many unique advantages. First of all, patients are in the supine position during MDCT scan, which is consistent with the surgical position. Secondly, MDCT is effective for the detection of tumor extension [12]. Beside, MDCT is convenient for 3-dimensional (3D) reconstruction. MDCT guided 3D reconstruction has been widely used in clinic, including surgery guidance. Therefore, we speculate that WGL combined with MDCT can be helpful for precision breast conserving surgery (PBCS).

The aims of this cohort study were to determine whether WGL combined with MDCT guided 3D reconstruction could guide PBCS, and to access the cosmetic outcome reported by patients.

Study Design We did a single center, prospective, cohort study in one group of our department from August 2021 to June 2022. The treatment for all patients were discussed by the multi-disciplinary team in our center. The decision in this study was decided by shared decision-making between patients and multi-disciplinary teams. All procedures for the enrolled patients were performed by one surgeon. All CT images were processed by an experienced radiologist. All specimens were evaluated by two experienced pathologists.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •women with T1/T2 invasive breast cancer confirmed by core biopsy
  • •be suitable for BCS
  • •the tumor should be unilateral and unifocal which is clearly visible with US

排除标准

  • •patients with an extensive intraductal component in invasive cancer
  • •patients who were pregnant or breast-feeding
  • •patients receiving neoadjuvant therapies.

研究组 & 干预措施

PBCS

Experimental

patients enrolled in the PBCS group underwent precision breast conserving surgery guided by wire guided localization combined with MDCT guided 3D reconstruction.

干预措施: precision breast conserving surgery guided by wire guided localization combined with MDCT guided 3D reconstruction (Procedure)

Control

No Intervention

patients enrolled in the Control group underwent palpation guided breast conserving surgery

结局指标

主要结局

The sum of located margin resection widths

时间窗: 1 month post operation

The sum of the resection widths of located superior, inferior, lateral and interior margins

次要结局

  • the largest margin resection width(1 month post operation)
  • The specimen diameter(1 month post operation)
  • Operation time(intraoperative)
  • Patients reported outcomes(participants completed the scale at baseline (before surgery), 1 month post operation and 6 months post radiotherapy (RT))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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