A Phase II Study to Identify the Role of Exocrine Pancreatic Insufficiency in Pediatric Patients With Abdominal Pain (RAP) Who Are Undergoing Upper Endoscopy Using Synthetic Human Secretin
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Prevalence of pancreatic insufficiency in Pediatric cases undergoing upper endoscopy for Abdominal Pain
研究概览
简要总结
This is a 3-year prospective study too identify the role of exocrine pancreatic insufficiency in patients with abdominal pain who are undergoing upper endoscopy. An endoscopic pancreatic function test (ePFT) with secretin will be performed in children undergoing routine investigative EGD.
The goal of this study is to identify the role of exocrine pancreatic insufficiency in patients with abdominal pain who are undergoing upper endoscopy, who otherwise would be labelled as recurrent abdominal pain (RAP).
详细描述
Recurrent abdominal pain (RAP) is an often encountered complaint in children and adolescents. The evaluation of the child or adolescent with recurrent abdominal pain requires an understanding of the pathogenesis of abdominal pain, the most common causes of abdominal pain, and the typical patterns of presentation.
Children and adolescents frequently undergo esophagogastroduodenoscopy (EGD) to evaluate complaint and recurrent abdominal pain is a frequently cited reason for endoscopy. This is a standard procedure where an endoscope is passed through the mouth, esophagus, stomach and into the first part of the small intestine. With the camera at the end of the endoscope, the endoscopist is able to see the gross appearance of the upper digestive tract. Small biopsy samples are collected from the small intestine, stomach and esophagus to evaluate for mucosal injury, irritation, infection or other anomalies that could be contributing to the patient's symptoms. This is helpful for evaluation of histological changes, but does not provide information about its function.
Pancreatic stimulation testing with secretagogue (secretin, cholecystokinin) administration, and direct pancreatic fluid collection is considered a gold standard to assess the exocrine pancreatic function. Indirect testing of pancreatic function such as with urine or stool has much lower sensitivity and specificity compared to direct pancreatic fluid collection.
This is a prospective study where patients undergoing investigative EGD will have endoscopic pancreatic function test (ePFT) with secretin.
There will be two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Group 1- Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency
- •For Group 2- Patients undergoing diagnostic EGD who consent to undergo ePFT
排除标准
- •If it is an emergency EGD procedure
- •If the caregiver refuses to sign the consent form
- •Patient has undergone ePFT testing previously with a documented allergy to human secretin
- •Patients that require atropine at the time of sedation
研究组 & 干预措施
ChiRhoStim Group 2
Patients undergoing diagnostic EGD that consent to undergo ePFT.
干预措施: synthetic human secretin (Drug)
ChiRhoStim Group 1
Patients undergoing EGD with ePFT for symptoms of suspected or known pancreatic insufficiency.
干预措施: synthetic human secretin (Drug)
结局指标
主要结局
Prevalence of pancreatic insufficiency in Pediatric cases undergoing upper endoscopy for Abdominal Pain
时间窗: 2.5 years
Secretin stimulated exocrine pancreatic enzyme activity will be measured in patients with abdominal pain who are undergoing upper endoscopy to identify those with insufficiency (EPI).
次要结局
- Secondary biomarkers for exocrine pancreatic insufficiency in blood and pancreatic fluid will be measured to explore mechanisms involved leading to abdominal pain and become potential tests in future.(2.5 years)
研究者
Devendra Mehta
Director, Pediatric Gastroenterology Laboratory, Arnold Palmer Hospital for Children
Orlando Health, Inc.