Pediatric Longitudinal Cohort Study of Chronic Pancreatitis



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any - 18
Updated:2/23/2018
Start Date:March 16, 2017
End Date:March 2023
Contact:Ziding Feng, PHD
Email:CR_Study_Registration@mdanderson.org
Phone:713-563-4276

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Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible
for the coordination and data management for the Pediatric Longitudinal Cohort Study of
Chronic Pancreatitis (INSPPIRE 2), which is part of the NIH U01 funded Consortium for the
Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). All patient
recruitment will occur at external sites that are a part of the CPDPC. The data management
systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center
Clinical Research Support Center (CRSC).


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.

3. All children providing samples should fit the ARP or CP inclusion criteria defined
below.

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.

Chronic Pancreatitis:

Children with at least:

1. one irreversible structural change* in the pancreas with or without abdominal pain and

ONE of the two conditions below:

2. exocrine pancreatic insufficiency

3. 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:

1. 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.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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