Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- EUS Pancreatic Findings- Rosemont Criteria
研究概览
简要总结
The main reason for this research study is to find out more about acute recurrent pancreatitis and chronic pancreatitis in children. There are few studies on childhood pancreatitis, so diagnosis and treatment are based on adult studies. This limits our understanding and treatment of these disorders in children.
Endoscopic ultrasound (EUS) is a tool used to assess and diagnose pancreatic disease. We can use ultrasound with shear wave elastography (SWE) to measure fibrosis (scarring) of the pancreas. We can use SWE on both EUS and transabdominal ultrasound (TUS) systems. Both TUS and EUS SWE have been studied for diagnosis of chronic pancreatitis in adult patients, however they have not been studied in children.
We plan to use EUS SWE and TUS SWE information in this study to help us understand pancreatitis in children. Children with pancreatitis and children without pancreatitis (controls) will be invited to participate in this study.
详细描述
The aims of the proposed study are as follows:
Aim 1: Characterize endoscopic ultrasound (EUS) findings of pediatric acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP).
Adult criteria for EUS diagnosis of CP exist, but no such criteria exist for children. As such, the applicability of current diagnostic criteria to pediatric patients is unknown.
1.1: Catalogue grayscale EUS findings of ARP and CP in a pediatric cohort and compare to healthy controls. Hypothesis: EUS findings of ARP and CP in pediatric patients will differ from those of adult ARP and CP and will be characteristically different from healthy controls. Exp1: We will catalogue grayscale EUS findings in 40 pediatric
patients with known history of ARP or CP undergoing clinically indicated EUS and will compare those with findings in 20 patients without a history of pancreatitis who are undergoing EUS for other indications.
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
- 0 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
EUS Pancreatic Findings- Rosemont Criteria
时间窗: At time of EUS procedure
Rosemont Criteria Features * Hyperechoic foci with shadowing (Major A) * Lobularity with honeycombing (Major B) * Lobularity without honeycombing (Minor) * Hyperechoic foci without shadowing (Minor) * Cysts (Minor) * Stranding (Minor) * Main pancreatic duct calculi (Major A) * Irregular main pancreatic duct contour (Minor) * Dilated side branches (Minor) * Main pancreatic duct dilation (Minor) * Hyperechoic main pancreatic duct margin (Minor)
次要结局
- Acute Recurrent Pancreatitis(6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound))
- Diabetes Mellitus(6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound))
- Calculated BMI(6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound))
- Chronic Pancreatitis(6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound))
- Exocrine Pancreatic Insufficiency(6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound))
- MRI Cambridge Grade: Mild(At time of MRI)
- ERCP Cambridge Criteria: Mild(At time of ERCP)
- EUS Rosemont Classification - Normal(At time of EUS)
- EUS Rosemont Classification - Suggestive of CP(At time of EUS)
- EUS Rosemont Classification - Indeterminate for CP(At time of EUS)
- MRI Cambridge Grade: Normal(At time of MRI)
- EUS Rosemont Classification - Consistent With CP(At time of EUS)
- ERCP Cambridge Criteria: Equivocal(At time of ERCP)
- MRI Cambridge Grade: Equivocal(At time of MRI)
- MRI Cambridge Grade: Moderate(At time of MRI)
- MRI Cambridge Grade: Severe(At time of MRI)
- ERCP Cambridge Criteria: Normal(At time of ERCP)
- ERCP Cambridge Criteria: Moderate(At time of ERCP)
- ERCP Cambridge Criteria: Marked(At time of ERCP)
研究者
David Vitale MD
Assistant Professor
Children's Hospital Medical Center, Cincinnati