Pediatric Longitudinal Cohort Study of Chronic Pancreatitis

Completed

Conditions studied: Pancreatitis, Chronic, Pancreatitis, Acute

In brief

The investigators will enroll a total of 628 patients under 18 years of age with ARP or CP. Included in the total are the 357patients in the INSPPIRE 1 database who are planned to be reenrolled under this protocol over the next 4 years. Patient questionnaires and physician surveys will be applied at the time of enrollment and annually thereafter as long as possible. At the first study visit after turning 18 years of age, the patient will sign the informed consent to continue in the study. Specifically, the investigators will define the demographics of the pediatric ARP and CP cohort, describe risk factors, presence of family history of acute and chronic pancreatitis, diabetes and pancreatic cancer and assess disease burden and sequelae.

Key facts

Study ID: NCT03672422
Run by: Aliye Uc
People needed: 623
Starts: 2017-06-30
Expected to finish: 2020-08-31
Last updated by the study team: 2020-11-06

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
3 All children providing samples should fit the ARP or CP inclusion criteria defined below.
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:
Abdominal pain compatible with AP,
Serum amylase and/or lipase values ≥3 times upper limits of normal,
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:
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).

You may not qualify if…

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.

Where it is running

Cedars-Sinai Medical Center — Beverly Hills, California, United States
Children's Hospital Los Angeles — Los Angeles, California, United States
University of California San Francisco — San Francisco, California, United States
Stanford University — Stanford, California, United States
Riley Hospital for Children Indiana University — Indianapolis, Indiana, United States
University of Iowa Stead Family Children's Hospital — Iowa City, Iowa, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
University of Minnesota Medical Center — Minneapolis, Minnesota, United States
Washington University — St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Nationwide Children's Hospital — Columbus, Ohio, United States
Children's Hospital of Philadelphia — Philipsburg, Pennsylvania, United States
Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
Children's Health University of Texas Southwestern Medical Center — Dallas, Texas, United States
Texas Children's Hospital — Houston, Texas, United States
Primary Children's Hospital — Salt Lake City, Utah, United States
Seattle Children's Hospital — Seattle, Washington, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Sydney Children's Hospital Randwick — Randwick, New South Wales, Australia
The Hospital for Sick Children — Toronto, Ontario, Canada
Montreal Children's Hospital — Montreal, Quebec, Canada
Hadassah University Hospital Mt. Scopus — Jerusalem, Israel

Full record on ClinicalTrials.gov

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