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临床试验/NCT05676866
NCT05676866尚未招募4 期

Evaluation of Targeted Axillary Lymph Nodes Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy

Assiut University0 个研究点目标入组 30 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
入组人数
30
主要终点
Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients

研究概览

简要总结

evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy

详细描述

Targeted axillary dissection (TAD) is a novel technique in the field of surgical oncology. During TAD, patients with node-positive breast cancer who clinically responded to neoadjuvant chemotherapy undergo resection of a previously proven metastatic node together with sentinel lymph node dissection (SLND).

Compared to sentinel lymph node dissection (SLND), axillary lymph node dissection [ALND] is associated with increased morbidity, higher rates of lymphedema, paraesthesia, sensory loss in the arm, and impairment in shoulder function. Patients undergoing SLND have fewer infections and a better quality of life, so axillary dissection has been largely replaced by SLND in early-stage breast cancer.

Targeted axillary dissection (TAD) is an innovative surgical procedure that emerged in an attempt to further decrease the false negative results of SLND.

Breast cancer patients suitable for neoadjuvant systemic therapy [NAST] with node-positive disease (N1,N2) were assessed by the multi-disciplinary team and if potentially eligible for TAD, a metallic marker[clip] is inserted in the suspicious node prior to neoadjuvant therapy.

The procedure is performed together with SLND using a single-tracer technique. Towards the end of NAST, a progress ultrasound and mammogram are performed to assess the breast and axillary response, Clip position within node is confirmed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • females with invasive breast cancer with axillary metastasis, staging of n1: n2
  • complete axillary response to neoadjuvant therapy by clinical examination and imaging

排除标准

  • breast cancer patients who are not candidate for neoadjuvant chemotherapy
  • breast cancer patients with positive axillary node post neoadjuvant chemotherapy
  • breast cancer patients with distant metastasis
  • patients with axillary lymph node metastasis from another primary tumour [not breast cancer]

结局指标

主要结局

Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients

时间窗: 3 monthes

Comparing sensetivity of targeted axillary dissection with traditional SLND

时间窗: 3 monthes

次要结局

  • Post operative complications: number of patients with arm lymphedema and sensory loss(3 monthes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Abdelnasser Mahmoud Ali

Resident doctor /Omar abdelnasser Mahmoud

Assiut University

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