|Principal Investigator: John Pohl|
|Keywords: Pancreatitis||Department: Pediatric Administration|
|IRB Number: 00099617|
|Specialty: Pediatrics, General|
|Recruitment Status: Recruiting|
Objective: To comprehensively characterize the pediatric population with Acute Recurrent Pancreatitis (ARP) and Chronic Pancreatitis (CP) and determine predictors of early onset CP and its sequelae.
Hypotheses: We hypothesize that childhood onset ARP follows a severe disease course with rapid progression to CP and early development of complications including persistent abdominal pain, growth and nutritional disturbances, exocrine pancreatic insufficiency, glycemic abnormalities, diabetes, repeated hospitalizations and procedures, all of which resulting in socioeconomic burden and an overall impaired quality of life. We also hypothesize that specific risk factors predispose children for early progression from ARP to CP, and specific risk factors predispose children to CP sequelae and high disease burden. Furthermore, prospective collection of biological samples from children with ARP and CP will provide a framework to develop biomarkers for early diagnosis of CP in children with ARP and to identify disease predictors such as genetic risk factors in development of CP and its complications including persistent abdominal pain, growth and nutritional disturbances, exocrine pancreatic insufficiency, glycemic abnormalities, diabetes.
All subjects/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study.
Subjects/parents must have signed an authorization for the release of their or their child’s protected health information.
All children providing samples should fit the ARP or CP inclusion criteria defined below.
4.4 All children must be 18 y/o or younger at the time of enrollment.
Acute pancreatitis (AP): AP is defined as requiring 2 of the following:
1) Abdominal pain compatible with AP,
2) Serum amylase and/or lipase values ≥3 times upper limits of normal,
3) Imaging findings of AP, such as gland enlargement, acute inflammatory changes, fluid collections.
ARP is defined as:
At least 2 episodes of acute pancreatitis with complete resolution of pain and a >1 month pain-free interval between episodes.
Children with at least:
one irreversible structural change* in the pancreas with or without abdominal pain +/- exocrine pancreatic insufficiency +/- diabetes.
ONE of the two conditions below:
exocrine pancreatic insufficiency
*irreversible structural changes:
Ductal calculi, dilated side branches, parenchymal calcifications found in any imaging (abdominal ultrasound (abd US), magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP), computerized tomography (CT), endoscopic retrograde cholangiopancreatography (ERCP), endoscopic US (EUS).
Ductal obstruction or stricture/dilatation/irregularities that are persistent (for >2 months) on any imaging.
Parenchymal atrophy, irregular contour, accentuated lobular architecture, cavities alone are not diagnostic findings for CP.
Surgical or pancreatic biopsy specimen demonstrating histopathologic features compatible with CP (acinar atrophy, fibrosis, protein plugs, infiltration with lymphocytes, plasma cells, macrophages).
4.5 Subjects must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate study interventions.