Indocyanine Green Near-infrared Fluorescence Bowel Perfusion Quantitative Assessment to Prevent Anastomotic Leakage in Colorectal Surgery: a Multicentre, Randomised, Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,268
- 试验地点
- 1
- 主要终点
- 30-days Anastomotic Leakage (AL) rate
研究概览
简要总结
Anastomotic leakage (AL) is a serious complication after surgery for colon cancer, leading to a significant increase in mortality.Intraoperative fluorescence imaging using indocyanine green has proven to be a feasible and reproducible technique for real-time perfusion assessment.
An increasing number of studies are being published on the use of indocyanine green (ICG) fluorescence imaging in colorectal cancer surgery, showing promising results.
Therefore, we propose conducting a multicenter, randomized controlled trial to investigate the potential use of quantitative assessment of near-infrared fluorescence imaging with indocyanine green (ICG) to prevent anastomotic leaks during colorectal surgery.
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
- Single (Participant)
盲法说明
Intraoperative imaging cannot blind the surgeon. The patient is only blinded prior to surgery.
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
- •Patients aged over 18 years old
- •ECOG status 0-2
- •Written informed consent
- •histologically confirmed neoplasms malignant of the colon (caecum, ascending, transverse, descending, sigmoid)
- •Scheduled for colorectal resection with primary anastomosis
排除标准
- •Pregnancy or breast feeding
- •Colon obstruction, perforation or bleeding complicating the tumor
- •Medical contraindications for surgical treatment
- •Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
研究组 & 干预措施
The ICG group
The ICG group, where, before creating the anastomosis, intestinal blood flow will be assessed using quantitative near-infrared fluorescence imaging using indocyanine green.
干预措施: ICG-guided bowel perfusion assessment (Drug)
The control group
The control group, where before the creation of the anastomosis, the intestinal blood flow will not be assessed.
干预措施: Conventional Bowel Anastomosis group (Other)
结局指标
主要结局
30-days Anastomotic Leakage (AL) rate
时间窗: 30-days
Anastomotic leakage rate
次要结局
- complication rate(30-days)
- mortality(30-days)
- days in hospital stay(90-days)
研究者
Vadim Kuznetsov
The doctor is a researcher
the BELOOSTROV Clinic of High Technologies