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临床试验/NCT02448953
NCT02448953Unknown不适用

Comparison of Lymph Node Dissection Results and Prognosis in Thoracic Esophageal Carcinoma Without Cervical Lymph Node Involvement: Two-field Versus Three-field Lymph Node Dissection

Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 786 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
786
试验地点
1
主要终点
Long term survival

研究概览

简要总结

The purpose of this study is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma patients without cervical lymph node involvement by preoperative CT and/or ultrasound treated by two-field lymphadenectomy or three-field lymphadenectomy.Another purpose of this study is to clarify whether the lymph node along the right recurrent laryngeal nerve can be taken as the sentinel lymph node which is able to indicate neck lymph node metastasis and necessity for three-field lymphadenectomy.

详细描述

Esophageal carcinoma is a prevalent and aggressive malignant disease with poor prognosis in China. Complete surgical resection with systemic lymph node dissection remains the most effective treatment method for this malignancy. Although tree-field lymph node dissection was reported to be effective in improving long-term survival in Japan,there is no enough evidences yet to demonstrate that three field lymph node dissection is superior to two field lymph node dissection in reducing postoperative recurrence and improving long-term survival. In this study, the dissection of lymph node adjacent to the right recurrent laryngeal nerve would be performed and examined routinely by intraoperative frozen-section. If the lymph node is positive, three field lymph node dissection(Cervical-thoracic-upper abdominal lymphadenectomy) will be performed, if negative, the patients will be randomly assigned either to three-field lymphadenectomy group or two-field lymphadenectomy group. The purpose of this large scale multi-center trial is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma without cervical lymph node involvement treated by three-field lymphadenectomy or two-field lymphadenectomy and clarify whether the lymph node along the right recurrent laryngeal nerve could be taken as sentinel lymph node indicating neck lymph node metastasis and necessity of three-field lymphadenectomy.

研究设计

研究类型
Interventional
分配方式
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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with histologically confirmed squamous cell esophageal cancer, without any previous anti-tumor therapy;
  • Preoperative clinical TNM stage:cT1b-3N0-1M0;
  • Adequate cardiopulmonary, liver, brain and kidney functions for esophagectomy either via right thoracotomy or VATS;
  • No evidence of suspicious neck lymph node metastasis (LN short diameter < 0.8cm or LN short/long diameter <0.65 by cervical CT and/or ultrasound);
  • Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail

排除标准

  • Previous use of anti-cancer therapy;
  • Preoperative clinical TNM stage: N2-3 or M1;
  • Inadequate cardiopulmonary,liver, brain and kidney function for surgery;
  • Previous malignancy history.
  • Suspicious neck lymph node metastasis (LN short diameter ≧0.8cm or LN short/long diameter ≧0.65 by cervical CT and/or ultrasound);
  • Unwilling to participate the clinical trial and refuse to sign informed consent.

结局指标

主要结局

Long term survival

时间窗: 5 years

次要结局

  • Locoregional recurrence(5 years)
  • Postoperative complications(3 years)
  • Disease free survival(5 years)

研究者

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

Jie He

president

Chinese Academy of Medical Sciences

研究点 (1)

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