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临床试验/NCT01351714
NCT01351714Unknown不适用

Safe D3 Right Hemicolectomy for Cancer Through 3D MDCT Angiography Reconstruction

Sykehuset i Vestfold HF4 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
700
试验地点
4
主要终点
Number of additional lymph nodes removed through radical D3 resection

研究概览

简要总结

When performing a resection of the right colon due to cancer one aims not only to remove the tumor bearing bowel segment, but also lymph nodes draining the affected area. These lymph nodes are located along the arteries supplying the right colon. Through using a preoperative CT scan which can map these arteries very precisely one can ligate these vessels closer to their origin and thus remove more lymph nodes which may potentially harbor cancer cells. This study aims to compare patients operated more radically through use of preoperative CT which maps the mentioned arteries with patients operated in the standard way.

详细描述

The Norwegian gastrointestinal cancer group has recommended D3 resection as the standard operative technique for colon cancer. D3 resection implies ligation of the blood vessels at their origin. There is evidence that the recurrence free period and survival improves with the number of lymph nodes harvested at surgery. However, the current practice in Norway, while performing right hemicolectomy for cancer is to ligate the feeding vessels for the right colon on the right hand side of the superior mesenteric vein (SMV). Significant arterial stumps have been demonstrated in patients operated for right colon cancer with this technique (right colic artery and ileocolic artery vascular stumps with an average length of 3.5 cm and 2.5 cm, respectively). This leaves reason to believe that a certain number of central lymph nodes remain after the procedure.

The complex anatomical relationship between the right colic artery and ileocolic artery with the superior mesenteric vein make D3 resection demanding, especially if the right colic artery lies posterior to the SMV. These relationships are investigated in detail in postmortem anatomical studies. These studies show that the right colic artery lies most often anterior to the SMV, while the ileocolic artery lies most often posterior to the SMV. Data has also been provided that a CT angiography can verify these relations as well as postmortem anatomical studies in living patients, thus allowing the surgeon to be aware of them prior to surgery. This could prove to be crucial in planning the procedure.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with histo-pathologically verified adeno-carcinoma of the right colon
  • Patients under the age of 75
  • Patients medically cleared by anesthesiologist for general anesthesia
  • Signed informed consent form

排除标准

  • Patients with recurrent cancer after previous surgery
  • Patients with distant metastasis
  • Patients who are not medically cleared to undergo anesthesia
  • Patients who do not sign the informed consent form

结局指标

主要结局

Number of additional lymph nodes removed through radical D3 resection

时间窗: 1 year

The short term outcome of this study will compare number of lymph nodes removed, operating time and complications between the two groups.

次要结局

  • Disease free survival 2 and 5 years after initial surgery(5 years)

研究者

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

Dejan Ignjatovic

MD, PhD, Professor

University Hospital, Akershus

研究点 (4)

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