Acute Recurrent Pancreatitis, Chronic Pancreatitis
Conditions
Brief summary
The main reason for this research study is to find out more about acute recurrent pancreatitis and chronic pancreatitis in children. There are few studies on childhood pancreatitis, so diagnosis and treatment are based on adult studies. This limits our understanding and treatment of these disorders in children. Endoscopic ultrasound (EUS) is a tool used to assess and diagnose pancreatic disease. We can use ultrasound with shear wave elastography (SWE) to measure fibrosis (scarring) of the pancreas. We can use SWE on both EUS and transabdominal ultrasound (TUS) systems. Both TUS and EUS SWE have been studied for diagnosis of chronic pancreatitis in adult patients, however they have not been studied in children. We plan to use EUS SWE and TUS SWE information in this study to help us understand pancreatitis in children. Children with pancreatitis and children without pancreatitis (controls) will be invited to participate in this study.
Detailed description
The aims of the proposed study are as follows: Aim 1: Characterize endoscopic ultrasound (EUS) findings of pediatric acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP). Adult criteria for EUS diagnosis of CP exist, but no such criteria exist for children. As such, the applicability of current diagnostic criteria to pediatric patients is unknown. 1.1: Catalogue grayscale EUS findings of ARP and CP in a pediatric cohort and compare to healthy controls. Hypothesis: EUS findings of ARP and CP in pediatric patients will differ from those of adult ARP and CP and will be characteristically different from healthy controls. Exp1: We will catalogue grayscale EUS findings in 40 pediatric patients with known history of ARP or CP undergoing clinically indicated EUS and will compare those with findings in 20 patients without a history of pancreatitis who are undergoing EUS for other indications. 1.2: Benchmark grayscale EUS against other imaging modalities for diagnosis of CP, particularly early CP, in children. Hypothesis: Grayscale EUS findings will be more sensitive than other imaging modalities in all stages of CP. Exp2: We will test associations, in blinded fashion, of grayscale EUS findings catalogued under S.A1.1 in enrolled children with findings on alternative pancreas imaging modalities performed for clinical indications. Specifically, we will correlate to endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP) and computed tomography (CT) performed for clinical indications within +/- 3 months of the EUS. Aim 2: Define the diagnostic performance of ultrasound elastography for CP and pancreatic stiffness as a measure of fibrosis in pediatric patients. 2.1: Define the diagnostic performance of EUS and TUS elastography for pediatric CP. Hypothesis: EUS and TUS elastography will have high specificity for CP with increased stiffness in patients compared to controls. Exp 1: Patients enrolled under Aim 1 will undergo shear wave elastography (SWE) measurement of the pancreas during EUS. These same patients will undergo research TUS with SWE of the pancreas. SWE results by both EUS and TUS will be evaluated for diagnostic performance for CP. 2.2: Define agreement between EUS and TUS measurement of pancreatic parenchymal stiffness in pediatric patients. Hypothesis: EUS and TUS measures of pancreatic parenchymal stiffness will agree with minimal bias. Exp2: EUS and TUS SWE data obtained under S.A2.1 will be evaluated for agreement and divergent cases will be investigated to define causes. 2.3: Define the diagnostic performance of elastography for pancreatic fibrosis. Hypothesis: SWE is a sensitive indicator of pancreatic fibrosis as identified by histology. Exp3: Patients undergoing clinically indicated total pancreatectomy and islet auto transplant (TPIAT) or other pancreatic surgical resection at our institution (approximately 20 per year) will be approached to undergo pre-operative TUS SWE. These SWE measurements, along with EUS SWE measurements obtained preoperatively, will be compared to binary and semi-quantitative assessments of pancreatic parenchymal fibrosis by histology.
Interventions
DIAGNOSTIC_TESTTransabdominal ultrasound Shear wave elastography
TUS SWE will be performed using a Canon Aplio i800 ultrasound system and a curved 1-6 MHz transducer. 2D SWE will be performed with measurement of shear wave speed in the head, body and tail of the pancreas.
Sponsors
David Vitale MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
Pancreatitis Cohort: Inclusion criteria: * Confirmed diagnosis of ARP or CP by INSPPIRE criteria * ≤ 21 years of age, male and female * Children undergoing EUS for clinical care * For Aim 2.3 only: Children undergoing TPIAT or other pancreatic resection
Exclusion criteria
* Children \<15 kg who cannot accommodate the size of endoscope * Children with acute pancreatitis (AP) \<6 weeks prior to EUS Control Cohort: Inclusion criteria: * Children without a history of pancreatic disease undergoing EUS for other clinical indications * ≤ 21 years of age, male and female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EUS Pancreatic Findings- Rosemont Criteria | At time of EUS procedure | Rosemont Criteria Features * Hyperechoic foci with shadowing (Major A) * Lobularity with honeycombing (Major B) * Lobularity without honeycombing (Minor) * Hyperechoic foci without shadowing (Minor) * Cysts (Minor) * Stranding (Minor) * Main pancreatic duct calculi (Major A) * Irregular main pancreatic duct contour (Minor) * Dilated side branches (Minor) * Main pancreatic duct dilation (Minor) * Hyperechoic main pancreatic duct margin (Minor) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Recurrent Pancreatitis | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) | The presence or absence of recurrence of pancreatitis. |
| Chronic Pancreatitis | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) | The presence or absence of Chronic pancreatitis diagnosis |
| Exocrine Pancreatic Insufficiency | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) | The presence or absence of exocrine pancreatic insufficiency diagnosis. |
| Diabetes Mellitus | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) | The presence or absence of a diagnosis of diabetes. |
| EUS Rosemont Classification - Normal | At time of EUS | The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification. Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin |
| EUS Rosemont Classification - Indeterminate for CP | At time of EUS | The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification. Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin |
| EUS Rosemont Classification - Suggestive of CP | At time of EUS | The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification. Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin |
| EUS Rosemont Classification - Consistent With CP | At time of EUS | The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification. Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin |
| MRI Cambridge Grade: Normal | At time of MRI | Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Severe) |
| Calculated BMI | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) | Capturing weight(kg) and height(cm) to calculate |
| MRI Cambridge Grade: Mild | At time of MRI | Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Severe) |
| MRI Cambridge Grade: Moderate | At time of MRI | Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Severe) |
| MRI Cambridge Grade: Severe | At time of MRI | Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked) |
| ERCP Cambridge Criteria: Normal | At time of ERCP | Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked) |
| ERCP Cambridge Criteria: Equivocal | At time of ERCP | Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked) |
| ERCP Cambridge Criteria: Mild | At time of ERCP | Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked) |
| ERCP Cambridge Criteria: Moderate | At time of ERCP | Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked) |
| ERCP Cambridge Criteria: Marked | At time of ERCP | Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked) |
| MRI Cambridge Grade: Equivocal | At time of MRI | Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Severe) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Children With Confirmed Diagnosis of ARP or CP Transabdominal ultrasound Shear wave elastography: TUS SWE will be performed using a Canon Aplio i800 ultrasound system and a curved 1-6 MHz transducer. 2D SWE will be performed with measurement of shear wave speed in the head, body and tail of the pancreas. | 39 |
| Controls (Children Without a History of Pancreatic Disease) Transabdominal ultrasound Shear wave elastography: TUS SWE will be performed using a Canon Aplio i800 ultrasound system and a curved 1-6 MHz transducer. 2D SWE will be performed with measurement of shear wave speed in the head, body and tail of the pancreas. | 20 |
| Total | 59 |
Baseline characteristics
| Characteristic | Children With Confirmed Diagnosis of ARP or CP | Total | Controls (Children Without a History of Pancreatic Disease) |
|---|---|---|---|
| Age, Continuous | 12.13 years | 13.12 years | 15.1 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 32 Participants | 51 Participants | 19 Participants |
| Region of Enrollment United States | 39 Participants | 59 Participants | 20 Participants |
| Sex: Female, Male Female | 19 Participants | 28 Participants | 9 Participants |
| Sex: Female, Male Male | 20 Participants | 31 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 21 |
| other Total, other adverse events | 0 / 45 | 0 / 21 |
| serious Total, serious adverse events | 0 / 45 | 0 / 21 |
Outcome results
Primary
EUS Pancreatic Findings- Rosemont Criteria
Rosemont Criteria Features * Hyperechoic foci with shadowing (Major A) * Lobularity with honeycombing (Major B) * Lobularity without honeycombing (Minor) * Hyperechoic foci without shadowing (Minor) * Cysts (Minor) * Stranding (Minor) * Main pancreatic duct calculi (Major A) * Irregular main pancreatic duct contour (Minor) * Dilated side branches (Minor) * Main pancreatic duct dilation (Minor) * Hyperechoic main pancreatic duct margin (Minor)
Time frame: At time of EUS procedure
Population: one test subject was excluded from the analysis because of unexpected findings of active acute pancreatitis at the time of the endoscopic ultrasound (EUS). This exclusion was necessary because acute pancreatitis can interfere with the evaluation of EUS findings related to chronic pancreatitis (CP) and acute recurrent pancreatitis (ARP).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | EUS Pancreatic Findings- Rosemont Criteria | Hyperechoic foci without shadowing | 49 percentage of participants |
| Children With Confirmed Diagnosis of ARP or CP | EUS Pancreatic Findings- Rosemont Criteria | Main pancreatic duct calculi | 10 percentage of participants |
| Children With Confirmed Diagnosis of ARP or CP | EUS Pancreatic Findings- Rosemont Criteria | lobularity without honeycombing | 36 percentage of participants |
| Children With Confirmed Diagnosis of ARP or CP | EUS Pancreatic Findings- Rosemont Criteria | Irregular main pancreatic duct contour | 49 percentage of participants |
| Children With Confirmed Diagnosis of ARP or CP | EUS Pancreatic Findings- Rosemont Criteria | Cysts | 10 percentage of participants |
| Children With Confirmed Diagnosis of ARP or CP | EUS Pancreatic Findings- Rosemont Criteria | Dilated side branches | 10 percentage of participants |
| Children With Confirmed Diagnosis of ARP or CP | EUS Pancreatic Findings- Rosemont Criteria | Lobularity with honeycombing | 26 percentage of participants |
| Children With Confirmed Diagnosis of ARP or CP | EUS Pancreatic Findings- Rosemont Criteria | Main pancreatic duct dilation | 15 percentage of participants |
| Children With Confirmed Diagnosis of ARP or CP | EUS Pancreatic Findings- Rosemont Criteria | Stranding | 79 percentage of participants |
| Children With Confirmed Diagnosis of ARP or CP | EUS Pancreatic Findings- Rosemont Criteria | Hyperechoic main pancreatic duct margin | 36 percentage of participants |
| Children With Confirmed Diagnosis of ARP or CP | EUS Pancreatic Findings- Rosemont Criteria | Hyperechoic foci with shadowing | 36 percentage of participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Pancreatic Findings- Rosemont Criteria | Hyperechoic main pancreatic duct margin | 0 percentage of participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Pancreatic Findings- Rosemont Criteria | Hyperechoic foci with shadowing | 0 percentage of participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Pancreatic Findings- Rosemont Criteria | Lobularity with honeycombing | 0 percentage of participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Pancreatic Findings- Rosemont Criteria | lobularity without honeycombing | 20 percentage of participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Pancreatic Findings- Rosemont Criteria | Hyperechoic foci without shadowing | 15 percentage of participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Pancreatic Findings- Rosemont Criteria | Cysts | 0 percentage of participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Pancreatic Findings- Rosemont Criteria | Stranding | 55 percentage of participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Pancreatic Findings- Rosemont Criteria | Main pancreatic duct calculi | 0 percentage of participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Pancreatic Findings- Rosemont Criteria | Irregular main pancreatic duct contour | 0 percentage of participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Pancreatic Findings- Rosemont Criteria | Dilated side branches | 0 percentage of participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Pancreatic Findings- Rosemont Criteria | Main pancreatic duct dilation | 0 percentage of participants |
Secondary
Acute Recurrent Pancreatitis
The presence or absence of recurrence of pancreatitis.
Time frame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Population: This is a description of the number of subjects in the ARP/CP cohort who have been diagnosed with ARP. 0 Healthy controls would have ARP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | Acute Recurrent Pancreatitis | 10 Participants |
Secondary
Calculated BMI
Capturing weight(kg) and height(cm) to calculate
Time frame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Population: BMI calculated from height and weight. Some participants did not have height and/or weight data available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | Calculated BMI | 21.3 kg/m2 |
| Controls (Children Without a History of Pancreatic Disease) | Calculated BMI | 30.5 kg/m2 |
Secondary
Chronic Pancreatitis
The presence or absence of Chronic pancreatitis diagnosis
Time frame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Population: Description of the number of participants in the ARP/CP group with CP diagnosis. Healthy controls were not evaluated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | Chronic Pancreatitis | 29 Participants |
Secondary
Diabetes Mellitus
The presence or absence of a diagnosis of diabetes.
Time frame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Population: A description of the presence or absence of a diagnosis of diabetes in the ARP/CP cohort as well as healthy controls.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | Diabetes Mellitus | 10 Participants |
| Controls (Children Without a History of Pancreatic Disease) | Diabetes Mellitus | 0 Participants |
Secondary
ERCP Cambridge Criteria: Equivocal
Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked)
Time frame: At time of ERCP
Population: The number of participants with Equivocal based on ERCP Cambridge Criteria. Healthy controls were not analyzed here.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | ERCP Cambridge Criteria: Equivocal | 4 Participants |
Secondary
ERCP Cambridge Criteria: Marked
Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked)
Time frame: At time of ERCP
Population: The number of participants with Marked based on ERCP Cambridge Criteria. Healthy controls were not analyzed here.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | ERCP Cambridge Criteria: Marked | 15 Participants |
Secondary
ERCP Cambridge Criteria: Mild
Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked)
Time frame: At time of ERCP
Population: The number of participants with Mild based on ERCP Cambridge Criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | ERCP Cambridge Criteria: Mild | 1 Participants |
Secondary
ERCP Cambridge Criteria: Moderate
Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked)
Time frame: At time of ERCP
Population: The number of participants with Moderate based on ERCP Cambridge Criteria. Healthy controls were not analyzed here.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | ERCP Cambridge Criteria: Moderate | 8 Participants |
Secondary
ERCP Cambridge Criteria: Normal
Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked)
Time frame: At time of ERCP
Population: The number of participants with Normal based on ERCP Cambridge Criteria. Healthy controls were not analyzed here.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | ERCP Cambridge Criteria: Normal | 0 Participants |
Secondary
EUS Rosemont Classification - Consistent With CP
The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification. Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin
Time frame: At time of EUS
Population: The number of participants with Consistent with CP based on Rosemont Criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | EUS Rosemont Classification - Consistent With CP | 10 Participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Rosemont Classification - Consistent With CP | 0 Participants |
Secondary
EUS Rosemont Classification - Indeterminate for CP
The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification. Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin
Time frame: At time of EUS
Population: The number of participants with Indeterminate for CP based on Rosemont Criteria
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | EUS Rosemont Classification - Indeterminate for CP | 11 Participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Rosemont Classification - Indeterminate for CP | 1 Participants |
Secondary
EUS Rosemont Classification - Normal
The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification. Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin
Time frame: At time of EUS
Population: The number of subjects without any indications of CP based on Rosemont criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | EUS Rosemont Classification - Normal | 6 Participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Rosemont Classification - Normal | 19 Participants |
Secondary
EUS Rosemont Classification - Suggestive of CP
The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification. Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin
Time frame: At time of EUS
Population: The number of participants with Suggestive of CP based on Rosemont Criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | EUS Rosemont Classification - Suggestive of CP | 12 Participants |
| Controls (Children Without a History of Pancreatic Disease) | EUS Rosemont Classification - Suggestive of CP | 0 Participants |
Secondary
Exocrine Pancreatic Insufficiency
The presence or absence of exocrine pancreatic insufficiency diagnosis.
Time frame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Population: A description of the presence or absence of exocrine pancreatic insufficiency diagnosis in the ARP/CP cohort. Healthy controls were also evaluated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | Exocrine Pancreatic Insufficiency | 2 Participants |
| Controls (Children Without a History of Pancreatic Disease) | Exocrine Pancreatic Insufficiency | 0 Participants |
Secondary
MRI Cambridge Grade: Equivocal
Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Severe)
Time frame: At time of MRI
Population: The number of participants with Equivocal based on MRI Cambridge Grade criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | MRI Cambridge Grade: Equivocal | 0 Participants |
| Controls (Children Without a History of Pancreatic Disease) | MRI Cambridge Grade: Equivocal | 0 Participants |
Secondary
MRI Cambridge Grade: Mild
Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Severe)
Time frame: At time of MRI
Population: The number of participants with Mild based on MRI Cambridge Grade criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | MRI Cambridge Grade: Mild | 0 Participants |
| Controls (Children Without a History of Pancreatic Disease) | MRI Cambridge Grade: Mild | 0 Participants |
Secondary
MRI Cambridge Grade: Moderate
Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Severe)
Time frame: At time of MRI
Population: The number of participants with Moderate based on MRI Cambridge Grade criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | MRI Cambridge Grade: Moderate | 5 Participants |
| Controls (Children Without a History of Pancreatic Disease) | MRI Cambridge Grade: Moderate | 0 Participants |
Secondary
MRI Cambridge Grade: Normal
Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Severe)
Time frame: At time of MRI
Population: The number of participants with Normal based on MRI Cambridge Grade criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | MRI Cambridge Grade: Normal | 4 Participants |
| Controls (Children Without a History of Pancreatic Disease) | MRI Cambridge Grade: Normal | 2 Participants |
Secondary
MRI Cambridge Grade: Severe
Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked)
Time frame: At time of MRI
Population: The number of participants with Severe based on MRI Cambridge Grade criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | MRI Cambridge Grade: Severe | 8 Participants |
| Controls (Children Without a History of Pancreatic Disease) | MRI Cambridge Grade: Severe | 0 Participants |