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临床试验/CTRI/2024/02/062933
CTRI/2024/02/062933尚未招募4 期

Comparison of 0.4 ml vs 0.6 ml diluted India ink solution for tattooing of axillary lymph nodes in the patient with breast cancer - a randomized controlled trial

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
46
试验地点
1
主要终点
comparison of Identification rates of tattooed tissue during modified radical mastectomy in two intervention arms.

研究概览

简要总结

The axillary dissection is performed in breast cancer patients with metastatic axillary lymph nodes. This axillary dissection is associated with significant morbidity. The recent studies suggest that probably it can be spared in patients who have responded well to neo-adjuvant chemotherapy. In patients where nodes have disappeared targeted axillary dissection (TAD) is emerging as an alternative. Here the axillary dissection is performed only when the pre marked or the sentinel lymph nodes are positive. However, this is not universally accepted and more studies are required before inducting it into the common practice. TAD was successful in 97% of patients. We are therefore planning to find the efficacy of 0.4ml and 0.6ml India ink solution for TAD and to compare the efficacy of two different doses of the agent. To determine the optimum dose of India ink solution for TAD.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
Female

入选标准

  • a) CA Breast with TNM Stage- T2-4, N
  • b) Clinically palpable axillary lymph nodes.

排除标准

  • a) More than two discrete and enlarged axillary lymph nodes. b) Axillary lymph nodes.
  • less than 1cm (difficult to hold) and more than 5 cm (targeting not practical). c) N stage -N2, N
  • d) Inflammatory breast cancer e) B/L Breast cancer f) Male breast cancer g) Family history suggestive of BRCA1 and BRCA2 gene mutation.

结局指标

主要结局

comparison of Identification rates of tattooed tissue during modified radical mastectomy in two intervention arms.

时间窗: During mastectomy or day 0: for identification of tattooed nodes | Follow up at daily till the day | of discharge. | 10th day for stitch removal | 15th day for Histopathology review. | One month: wound Evaluation | Third Month: wound and axilla review. | Sixth Month.

次要结局

  • Response rate with neo- adjuvant chemotherapy(At Three months from start of chemotherapy)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Mithilesh Kumar Sinha

AIIMS BHUBANESWAR

研究点 (1)

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