Sentinel Node Mapping With Indocyanine Green in Colon Cancer: a Feasibility Trial and a Descriptive Serie.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of procedures with successful identification of sentinel nodes
研究概览
简要总结
This study is a clinical feasibility trial that will contribute to the clarification of whether sentinel node mapping with indocyanine green (ICG) provides a better basis for staging of colorectal cancer.
详细描述
The patients assigned for colon cancer will be operated as planned using laparoscopic techniques and the operation follows the normal procedure, in addition a sentinel node mapping is performed.
Indocyanine green is injected around the tumor by laparoscopic technique, the fluorescence is controlled and after 20 minutes the surgeon looks for sentinel nodes in a standardized manner. In the meantime, the surgeon proceeds with the operation as usual, except that the mesocolon can be resected only after sentinel node mapping has been performed.
After surgery the surgeon and the pathologist inspect the resected colon together and agree on D1, D2 and D3 margins. Any marked sentinel node(s) is verified and the location is checked on the colon diagram on the case report form. In addition, an ex vivo sentinel node mapping will be performed by the pathologist right after the surgery has ended. This is done to investigate if it is the same lymph nodes there will be identified by ex vivo as by intraoperative (in vivo) sentinel node mapping.
The lymph nodes in the resected colon and mesocolon are all analysed. Sentinel nodes and an equal number of randomly chosen non-sentinel nodes will be analysed further with additional sections and immune histochemistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients above 18 years of age scheduled for laparoscopic colon cancer surgery in the department of Surgery, Herlev Hospital or Roskilde Hospital.
排除标准
- •iodine allergy
- •Poor kidney function (as it imply an increased risk of allergic reaction), estimated glomerular filtration rate should be above 40 ml/min.
- •Liver cirrhosis, Child-Pugh-score B and C [14]
- •Pregnancy and lactation
- •Previous anaphylactic reaction to a dye injection
- •Previous abdominal surgery
结局指标
主要结局
Number of procedures with successful identification of sentinel nodes
时间窗: day 1
Sentinel nodes is defined as the lymph node, first in line, draining from the cancer.
次要结局
- Number of sentinel nodes identified during surgery and their localization(day 1)
- Number of cases where the sentinel node procedure has changed the clinical course of the patient(week 1)
- Total number of lymph nodes(week 1)
- Number of sentinel nodes identified by ex vivo sentinel node mapping(week 1)
- Malignant status of the sentinel node(s)(week 1)
- Malignant status of the lymph nodes(week 1)
- Number of procedures where the procedure is stopped due to technical reasons(day 1)
- Number of cases with negative sentinel node, but positive non-sentinel node(week 1)
- Localization of sentinel nodes with metastasis(week 1)
- Localization of lymph nodes with metastasis according to D1, D2 and D3 resection lines and if they are within 1 cm from a sentinel node(week 1)
- Registration of possible side effects occurring due to the use of indocyanine green(day 1)
- Number of sentinel nodes identified by only one of the sentinel node mapping techniques(week 1)
- Localization of the identified sentinel nodes, and whether or not they are included within the normal resection lines(week 1)
研究者
Ismail Gögenür
Professor, DMSc, MD
Herlev Hospital