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临床试验/NCT04848311
NCT04848311Unknown不适用

Indocanine Green as Tracer for Lymph Nodes Dissection in Station 253 of Rectal and Sigmoid Colon Carcinoma

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
66
试验地点
1
主要终点
number of harvested station 253 lymph nodes

研究概览

简要总结

This is a prospective randomized controlled study. investigators will randomly assign patients to the indocanine green (ICG) group and control (CL)group to compare the differences of lymph nodes dissection in station 253 between the two groups.

详细描述

ICG is a registered and FDA-approved non-specific fluorescent probe for optical imaging in clinical settings. The properties of ICG ,which is a water-soluble amphiphilic molecule with a molecular weight of 775 Dalton and a hydrodynamic diameter of 1.2nm ,render it an excellent lymphatic contrast agents if injected into the lymphatic system. ICG near-infrared(NIR) fluorescent imaging has achieved satisfactory results in the localization of sentinel lymph nodes in patients with breast cancer,non-small cell lung cancer,and gastric cancer. Liang et al have suggested that 253 lymph nodes dissection in rectal cancer is technically demanding ,and that learning curve for laparoscopic 253 lymph nodes dissection requires minimally 20 procedures. Currently,it was still controversial about 253 lymph nodes dissection in rectal cancer surgery. However, lymph node involvement is a major prognostic factor for survival after rectal cancer surgery. Therefore, it is necessary to harvest more station 253 nodes for the better long-term survival and the more precise staging.

In this study, investigators will randomly assign patients to the indocanine green (ICG) group and control (CL)group. Number of harvested station 253 lymph nodes, number of positive station 253 lymph nodes, will be evaluated and compared. Investigators will also evaluate patients, operative time, blood loss, post-operative hospital stay and complications.

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
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
否

入选标准

  • •(1)18-80 years of age (2)American Society of Anesthesiologists (ASA) class 1-3 (3)single rectal or sigmoid colon carcinoma confirmed pathologically by endoscopic biopsy (4)planned laparoscopic radical resection (5)Written informed consent

排除标准

  • •previous abdominal tumor surgery
  • •women who are pregnant or breast feeding
  • •emergency patients with obstruction or perforation
  • •T4b cancer evaluated by CT or MRI or endoscopic ultrasonography
  • •pelvic or distant metastasis
  • •T1 cancer planned local excision
  • •allergic constitution patients

研究组 & 干预措施

ICG group

Experimental

Patients in the ICG group will undergo endoscopic injection of ICG 4 hours before surgery. The ICG powder will be dissolved in 2.5mg/ml of sterile water. ICG will be injected along the submucosa at 4 points around the primary tumor,for a total volume of 10ml.

干预措施: lymph nodes dissection at 253 station assisted by ICG (Procedure)

CLgroup

No Intervention

Patients in the CL group will undergo routine laparoscopic lymph nodes dissection instead of using any tracer.

结局指标

主要结局

number of harvested station 253 lymph nodes

时间窗: one week after operation

number of harvested station 253 lymph nodes,number of positive station 253 lymph nodes,rate of positive station 253 lymph nodes

次要结局

  • number of harvested station 251 lymph nodes(one week after operation)
  • number of harvested station 252 lymph nodes(one week after operation)
  • number of total lymph nodes harvested(one week after operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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