The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- SPY System utility in intestinal resections in Pediatric Surgery
研究概览
简要总结
Background: Intestinal resections are commonly performed in the pediatric population. Perfusion of the bowel is one of the most important factors determining the viability of an intestinal anastomosis. Up to date, no ideal method to assess intestinal perfusion has proven its superiority.
Objectives:
Primary: The aim of this study is to establish the feasibility and impact of the use of indocyanine green technology on intestinal resection margins during elective and emergency pediatric surgeries.
Secondary: The secondary outcomes of interest include collection of adverse events and difficulties encountered with the use of the indocyanine green (ICG) technology. Postoperative surgical complications will also be recorded.
Study Design: An open observational clinical study will be performed by using a clinical drug (indocyanine green) and medical device (SPY Fluorescence Imaging) to assess intraoperatively intestinal perfusion in a specific pediatric population.
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
- 0 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients < 16 years old
- •Admitted between September 2019 and September 2020
- •Patients undergoing a surgery at CHUSJ
- •Any diagnosis requiring intra-abdominal intestinal resection (including stoma reversal)
- •Written informed consent form from the parents or legal guardian
排除标准
- •Patients > 16 years old
- •Patients with known allergy or sensitivity to iodine
- •Patients with known kidney or liver failure
- •Patients with known severe cardiac or pulmonary diseases
- •Informed consent unobtained or impossible due to refusal of parents, language barrier, or diminished comprehension
研究组 & 干预措施
Patients undergoing intestinal resections
- Interventions to be administered: indocyanine green intravenous injection and subsequent visualisation of intestinal viability under fluorescence
- Drug:
Indocyanine green dye (ICG) Dosage: 0.5 mg/kg (diluted with aqueous solution) Maximum: 2 mg/kg Frequency: maximum of 3 boluses Duration: intraoperative use only
干预措施: SPY imaging (Device)
Patients undergoing intestinal resections
- Interventions to be administered: indocyanine green intravenous injection and subsequent visualisation of intestinal viability under fluorescence
- Drug:
Indocyanine green dye (ICG) Dosage: 0.5 mg/kg (diluted with aqueous solution) Maximum: 2 mg/kg Frequency: maximum of 3 boluses Duration: intraoperative use only
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
SPY System utility in intestinal resections in Pediatric Surgery
时间窗: 1 year
To demonstrate the utility of intra-operative evaluation of intestinal viability using the SPY Fluorescence Imaging System to optimize the location of the resection margins in pediatric surgeries necessitating intestinal resections. - Rate of intestinal resection margins modifications by using the SPY technology
次要结局
- Length of stay(1 year)
- Estimated blood losses(30 days)
- Need for additional reoperations(1 year)
- Surgical complications(1 year)
- Operative time(30 days)
- Need for additional radiology interventions(1 year)
研究者
Nelson Piche
Pediatric Surgeon
St. Justine's Hospital