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临床试验/NCT02753465
NCT02753465Unknown不适用

A Prospective Randomized Clinical Study for Laparoscopic D3 Lymph Node Dissection With Preservation of Left Colic Artery in Rectal Cancer Surgery

Fudan University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Number of lymph node dissection

研究概览

简要总结

During surgery for rectal cancer, there is considerable controversy regarding the optimal level of ligation of the inferior mesenteric artery. Several studies have demonstrated the benefit of high ligation of the inferior mesenteric artery for the rectal cancer in order to achieve block dissection of lymph node metastases along the root of the inferior mesenteric artery. In contrast, other studies have shown a significant decrease in blood flow after inferior mesenteric artery clamping that may increase the risk of anastomotic ischemia and the long-term outcomes were not significantly different between high ligation of the inferior mesenteric artery and low ligation. So, a modified procedure was suggested to dissect fatty tissues and nodes in the angle between the inferior mesenteric artery and the left colic artery and the artery was ligated below the left colic artery. In the present clinical trial, the investigators perform laparoscopic surgery with this management strategy in rectal cancer. Thus, the goal of this study is to investigate the short-term and oncologic long-term outcomes associated with laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer.

详细描述

During surgery for rectal cancer, there is considerable controversy regarding the optimal level of ligation of the inferior mesenteric artery.There has been a differentiation between a high versus low ligation of the inferior mesenteric artery related to whether or not the ligation is above (high ligation) or below (low ligation) the left colic artery. Several studies have demonstrated the benefit of high ligation of the inferior mesenteric artery for the rectal cancer in order to achieve block dissection of lymph node metastases along the root of the inferior mesenteric artery. Excision of the apical lymph node at the root of the inferior mesenteric artery is thought to be necessary for radical resection of rectal cancer because apical lymph node resection contributes to improve lymph node retrieval rates and the accuracy of tumour staging. In contrast, other studies have shown a significant decrease in blood flow after inferior mesenteric artery clamping that may increase the risk of anastomotic ischemia. Patients with high ligation of inferior mesenteric artery had a 3.8 times higher chance of leaking than those with low ligation. Several studies confirmed that the long-term outcomes were not significantly different between high ligation of the inferior mesenteric artery and low ligation. So, a modified procedure was suggested to dissect fatty tissues and nodes in the angle between the inferior mesenteric artery and left colic artery and the artery was ligated below the left colic artery, which represented a compromise between the high and low ligation. Recently, several studies have described laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectosigmoid colon cancer. However, there are a few reports that describe the clinical outcomes associated with this management strategy. Furthermore, the long-term outcomes for laparoscopic lymphadenectomy around the inferior mesenteric artery with rectal cancer have seldom been reported. In the present clinical trial, the investigators perform laparoscopic surgery with this management strategy in rectal cancer. Thus, the goal of this study is to investigate the short-term and oncologic long-term outcomes associated with laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • pathological confirmed rectal adenocarcinoma
  • solitary radical resectable tumors
  • tumor located at 5-15cm from the anus

排除标准

  • recurrent cases
  • emergency including obstruction, bleeding or perforation
  • severe abdominal adhesions
  • severe malnutrition can not be improved before surgery
  • can not tolerate to surgery due to severe comorbidities of heart, lung, liver or kidney
  • refractory hypoproteinemia or diabetes mellitus
  • previous or concomitant other cancers
  • the patients performed APR or hartmann surgery

结局指标

主要结局

Number of lymph node dissection

时间窗: 10 days since the date of surgery

disease-free survival rate

时间窗: 3 years since the date of surgery

3 years disease-free survival rate after surgery

anastomotic leak rate

时间窗: 30 days since the date of surgery

percentage of patients occuring anastomotic leak within 30 days since surgery

Overall survival rate

时间窗: 3 years since the date of surgery

3 years total survival rate after surgery

次要结局

  • 30-day mortality rate(within 30 days since the date of surgery)

研究者

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

LI XIN-XIANG

professor of colorectal surger

Fudan University

研究点 (1)

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