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临床试验/NCT02942238
NCT02942238Unknown不适用

Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)

Ruijin Hospital0 个研究点目标入组 582 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
582
主要终点
Disease-free survival

研究概览

简要总结

To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether extended lymphadenectomy (CME) could improve disease-free survival in patients with right colon cancer, compared with D3 radical operation in laparoscopic colectomy.

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
Double (Participant, Outcomes Assessor)

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 suitable for curative surgery 18-75years old
  • Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
  • Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
  • Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T stage 1-4 and N stage 0-2; there is no distant metastasis.
  • Informed consent

排除标准

  • Simultaneous or simultaneous multiple primary colorectal cancer;
  • Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection;
  • History of any other malignant tumor in recent 5 years;
  • Patients need emergency operation;
  • Not suitable for laparoscopic surgery;
  • Women during Pregnancy or breast feeding period;
  • Informed consent refusal

结局指标

主要结局

Disease-free survival

时间窗: 3 years

次要结局

  • The rate of local and distant recurrence(3 years)
  • The accuracy of preoperative staging with CT(14 days)
  • 3 years overall survival(3 years)
  • The rate of postoperative complications and mortality(30 days)

研究者

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

Minhua Zheng

professor

Ruijin Hospital

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