Indocyanine Green Fluorescence Angiography Mediated Assessment of Gastro-Intestinal Perfusion in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Feasibility of ICG-FA for intraoperative assessment of intestinal perfusion
研究概览
简要总结
The goal of this clinical trial is to test the use of the SPY-PHI device for the purpose of ICG-mediated intestinal perfusion visualization during gastrointestinal surgery in neonates and young infants (<3 months old) undergoing surgery for NEC, atresia, SIP or malrotation. The main question[s] it aims to answer are:
- Is ICG-FA feasible for intraoperative use in neonates and young infants undergoing laparotomy for NEC, atresia, SIP or malrotation?
- Is ICG-FA is safe to use in neonates during surgery?
Participants will undergo surgical care for their diseases within the standard of care. During laparotomy, the pediatric surgeon will assess bowel perfusion in two ways. First, by visual inspection (the conventional method). Second, the intestine will be analyzed with indocyanine green fluorescence angiography (ICG-FA) by means of the hand-held SPY-PHI camera. For this purpose, the patients will be administered ICG intravenously. Afterwards, the intestinal perfusion will be assessed by means of the SPY-PHI device in 5 to 10 minutes.
Specifically, the feasibility and safety for use of ICG-FA in neonates undergoing laparotomy as treatment for necrotizing enterocolitis (NEC), atresia, spontaneous intestinal perforation (SIP) and malrotation will be investigated.
If ICG-FA turns out to be feasible and safe for the population investigated in this study, a follow-up study will be conducted with the aim to explore the potential benefits of this technique on the postoperative outcome and intraoperative decision-making.
详细描述
This study aims to investigate whether the intraoperative use of indocyanine green fluorescence angiography (ICG-FA) is feasible and safe in neonates. Feasibility is therein defined as practically possible use of ICG-FA, resulting in clear and interpretable results, with the future potential to improve clinical outcome and benefits for the patient.
Specifically, the feasibility and safety for use of ICG-FA in neonates undergoing laparotomy as treatment for necrotizing enterocolitis (NEC), atresia, spontaneous intestinal perforation (SIP) and malrotation will be investigated.
If ICG-FA turns out to be feasible and safe for the population investigated in this study, a follow-up study will be conducted with the aim to explore the potential benefits of this technique on the postoperative outcome and intraoperative decision-making.
The primary endpoint of this study is assessing the feasibility and safety of intraoperative ICG-FA imaging in neonates undergoing laparotomy for NEC, atresia, SIP, or malrotation. The secondary endpoint of this study is postoperative comparison of the images; standard visual inspection (conventional image) with the corresponding fluorescence image.
During laparotomy, first the pediatric surgeon performs the visual inspection of the predetermined areas (mid jejunum, ileum, ascending colon and sigmoid) as well as regions of interest such as ischemic lesions in NEC and malrotation with volvulus. In case of intestinal necrosis, both edges of the parts that will be resected must be marked with a suture. Second, the intestine will be analyzed using ICG-FA. This analysis will cover the predetermined areas as well as regions of interest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent is obtained by both patient's parents or legal guardians (as applicable);
- •Patient is a neonate (< 1 month of age) or young infant (<3 months of age);
- •Patient is suffering from necrotizing enterocolitis, atresia, malrotation or spontaneous intestinal perforation;
- •Patient requires laparotomy for management of the disease.
排除标准
- •Patient is suffering from clinically significant (treatment necessary) hyperbilirubinemia;
- •Patient is suffering from thyroid or liver disease;
- •Patient is allergic to the active substance indocyanine green or sodium iodide or iodine;
- •Patient has abdominal wall defects;
- •Patient can be treated non-surgically;
- •During the preoperative multidisciplinary meeting with the team, including the pediatric anesthetist, patient is deemed not stable enough hemodynamically to perform the ICG-FU measurements
- •Patient is assessed unstable by operating team intraoperatively.
结局指标
主要结局
Feasibility of ICG-FA for intraoperative assessment of intestinal perfusion
时间窗: 10 minutes intraoperatively (recording)
a. Possibility for the researchers to assess intestinal perfusion based on the intraoperative ICG-FA images (clarity: yes/no);
Safety of intraoperative ICG-FA in gastrointestinal surgery for young infants and neonates
时间窗: 24 hours
a. Number of complications directly related to use of the device or extension of operative time for ICG-FA imaging, occurring within 24 hours after surgery in the patients involved in this study;
次要结局
- Comparison of conventional and ICG-FA mediated assessment(Through study completion, on average within 4 weeks)