Chronic Pancreatitis: Pediatric Longitudinal Cohort Study

What is the Purpose of this Study?

Only a few research studies have focused on pancreatitis in children, which limits what we know about pancreatitis in children and how to treat it. In this study, researchers will collect blood or saliva for genetic analysis, urine (for biomarker analysis), clinical data, and questionnaires from children with all types of pancreatitis. The study will continue to collect questionnaires from participants until they are 18 years old. (Participants may answer questionnaires for as long as they choose after the age of 18). Researchers hope to use the samples and data to learn how common pancreatitis is in children, what causes pancreatitis, and how it progresses (gets worse). The study will evaluate lab results, images, and response to treatment. In so doing, researchers aim to develop better tests and treatments for the disease.

Eligibility

1. All patients/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study.
2 Patients/parents must have signed an authorization for the release of their or their child's protected health information.

Inclusion Criteria:

1. All patients/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study.
2 Patients/parents must have signed an authorization for the release of their or their child's protected health information.
4 All children must be under 18 years of age 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, and 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.
Chronic Pancreatitis:
Children with at least:
1. One irreversible structural change\* in the pancreas with or without abdominal pain +/- exocrine pancreatic insufficiency +/- diabetes.
\*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).

Exclusion Criteria:

* Patients 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.

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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center

More about this Clinical Trial

What is the full name of this clinical trial?

EIIT-CPDPC16-03: Pediatric Longitudinal Cohort Study of Chronic Pancreatitis ^

Study Details

Disease Type/Condition

Pancreas

Principal Investigator

Liu, Quin

Co-Investigators

Stephen Pandol

Age Group

Children

Phase

N/A (Cancer Control)

IRB Number

Pro00048977

ClinicalTrials.gov ID

NCT03672422

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org