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临床试验/NCT02495532
NCT02495532Unknown不适用

Randomized Clinical Trial Comparing Carnoy's and GEWF Solutions for Lymph Node Clearing Technique in Colorectal Cancer

Hospital Moinhos de Vento2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
126
试验地点
2
主要终点
Lymph nodes harvested

研究概览

简要总结

Regional lymph node metastasis is a major determinant of local recurrence and overall survival rates in patients with colorectal cancer. Because of the poor prognosis associated with the presence of lymph node metastasis, stage III colorectal cancer patients should receive adjuvant treatment with chemo and / or radiation therapy according to the site of tumor. Several authors have investigated the use of revealing solutions for lymph node clearance in colorectal cancer. Most studies comparing conventional histopathological specimen examination to any lymph node clearing technique showed that the use of revealing solutions increases the mean number of lymph nodes harvested, usually in a statistically significant manner. It is still controversial the impact of the use of revealing solutions for upstaging of lymph node status and consequently for the indication for adjuvant therapy. Therefore will be conducted a randomized clinical trial to compares the performance of GEWF and Carnoy solutions for the histopathological examination of patients with colorectal cancer. The aim of this study is to determine the lymph node revealing solution with the best performance (increase in the mean number of lymph node harvested and lymph node upstaging) in patients with colorectal cancer.

详细描述

Patients with histologically proven colorectal adenocarcinoma submitted to curative resection and conventional histopathological examination of the surgical specimen are randomized to undergo further investigation by lymph node clearing technique with Carnoy or GEWF solution.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

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

入选标准

  • Histologically proven colorectal adenocarcinoma
  • Voluntary agreement of the patient to participate in research
  • Voluntary agreement of the surgeon to participate in research

排除标准

  • Absence of accurate histopathological data

结局指标

主要结局

Lymph nodes harvested

时间窗: One week

Number of additional lymph nodes harvested with the clearing technique

次要结局

  • Lymph node metastasis(One week)
  • Upstage of lymph nodes(One week)
  • Adjuvant therapy(One month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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