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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TUS SWE | Experimental | This arm includes two cohorts:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transabdominal ultrasound Shear wave elastography | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| EUS Pancreatic Findings- Rosemont Criteria | Rosemont Criteria Features
| At time of EUS procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Calculated BMI | Capturing weight(kg) and height(cm) to calculate | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) |
| Acute Recurrent Pancreatitis | The presence or absence of recurrence of pancreatitis. |
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Pancreatitis Cohort:
Inclusion criteria:
Exclusion criteria:
Control Cohort:
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Vitale, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
45 subjects with ARP/CP were enrolled but only 39 completed the study. 21 controls were enrolled but only 20 completed the study. These 7 subjects were excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | EUS Pancreatic Findings- Rosemont Criteria | Rosemont Criteria Features
| 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). | Posted | Number | percentage of participants | At time of EUS procedure |
|
At time of EUS procedure and at time of MRCP or CT imaging
Per the IRB approved study protocol: "Adverse events related to the study procedures will be monitored by the study coordinator and reported to the PI. The PI will then report any adverse events in writing to the CCHMC IRB within the time frame specified in the IRB guidelines."
Only adverse events related to study procedures would be reported. No adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Vitale | Cincinnati Children's | (513) 517-7040 | David.Vitale@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2021 | Mar 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2022 | Jan 2, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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|
| 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) |
| Chronic Pancreatitis | The presence or absence of Chronic pancreatitis diagnosis | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) |
| Exocrine Pancreatic Insufficiency | The presence or absence of exocrine pancreatic insufficiency diagnosis. | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) |
| Diabetes Mellitus | The presence or absence of a diagnosis of diabetes. | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) |
| 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 | At time of EUS |
| 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 | At time of EUS |
| 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 | At time of EUS |
| 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 | At time of EUS |
| MRI Cambridge Grade: Normal | Cambridge Grade:
| At time of MRI |
| MRI Cambridge Grade: Equivocal | Cambridge Grade:
| At time of MRI |
| MRI Cambridge Grade: Mild | Cambridge Grade:
| At time of MRI |
| MRI Cambridge Grade: Moderate | Cambridge Grade:
| At time of MRI |
| MRI Cambridge Grade: Severe | Cambridge Grade:
| At time of MRI |
| ERCP Cambridge Criteria: Normal | Cambridge Criteria
| At time of ERCP |
| ERCP Cambridge Criteria: Equivocal | Cambridge Criteria
| At time of ERCP |
| ERCP Cambridge Criteria: Mild | Cambridge Criteria
| At time of ERCP |
| ERCP Cambridge Criteria: Moderate | Cambridge Criteria
| At time of ERCP |
| ERCP Cambridge Criteria: Marked | Cambridge Criteria
| At time of ERCP |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | 7 subjects (6 with ARP/CP and 1 control) were enrolled but did not complete the study and were not evaluable. These 7 subjects were excluded from analysis. | Count of Participants | Participants |
|
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. |
| OG001 | 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. |
|
|
| Secondary | Calculated BMI | Capturing weight(kg) and height(cm) to calculate | BMI calculated from height and weight. Some participants did not have height and/or weight data available. | Posted | Median | Inter-Quartile Range | kg/m2 | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) |
|
|
|
| Secondary | Acute Recurrent Pancreatitis | The presence or absence of recurrence of pancreatitis. | 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. | Posted | Count of Participants | Participants | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) |
|
|
|
| Secondary | Chronic Pancreatitis | The presence or absence of Chronic pancreatitis diagnosis | Description of the number of participants in the ARP/CP group with CP diagnosis. Healthy controls were not evaluated. | Posted | Count of Participants | Participants | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) |
|
|
|
| Secondary | Exocrine Pancreatic Insufficiency | The presence or absence of exocrine pancreatic insufficiency diagnosis. | A description of the presence or absence of exocrine pancreatic insufficiency diagnosis in the ARP/CP cohort. Healthy controls were also evaluated. | Posted | Count of Participants | Participants | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) |
|
|
|
| Secondary | Diabetes Mellitus | The presence or absence of a diagnosis of diabetes. | A description of the presence or absence of a diagnosis of diabetes in the ARP/CP cohort as well as healthy controls. | Posted | Count of Participants | Participants | 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) |
|
|
|
| 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 | The number of subjects without any indications of CP based on Rosemont criteria. | Posted | Count of Participants | Participants | At time of EUS |
|
|
|
| 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 | The number of participants with Indeterminate for CP based on Rosemont Criteria | Posted | Count of Participants | Participants | At time of EUS |
|
|
|
| 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 | The number of participants with "Suggestive of CP" based on Rosemont Criteria. | Posted | Count of Participants | Participants | At time of EUS |
|
|
|
| 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 | The number of participants with "Consistent with CP" based on Rosemont Criteria. | Posted | Count of Participants | Participants | At time of EUS |
|
|
|
| Secondary | MRI Cambridge Grade: Normal | Cambridge Grade:
| The number of participants with "Normal" based on MRI Cambridge Grade criteria. | Posted | Count of Participants | Participants | At time of MRI |
|
|
|
| Secondary | MRI Cambridge Grade: Equivocal | Cambridge Grade:
| The number of participants with "Equivocal" based on MRI Cambridge Grade criteria. | Posted | Count of Participants | Participants | At time of MRI |
|
|
|
| Secondary | MRI Cambridge Grade: Mild | Cambridge Grade:
| The number of participants with "Mild" based on MRI Cambridge Grade criteria. | Posted | Count of Participants | Participants | At time of MRI |
|
|
|
| Secondary | MRI Cambridge Grade: Moderate | Cambridge Grade:
| The number of participants with "Moderate" based on MRI Cambridge Grade criteria. | Posted | Count of Participants | Participants | At time of MRI |
|
|
|
| Secondary | MRI Cambridge Grade: Severe | Cambridge Grade:
| The number of participants with "Severe" based on MRI Cambridge Grade criteria. | Posted | Count of Participants | Participants | At time of MRI |
|
|
|
| Secondary | ERCP Cambridge Criteria: Normal | Cambridge Criteria
| The number of participants with "Normal" based on ERCP Cambridge Criteria. Healthy controls were not analyzed here. | Posted | Count of Participants | Participants | At time of ERCP |
|
|
|
| Secondary | ERCP Cambridge Criteria: Equivocal | Cambridge Criteria
| The number of participants with "Equivocal" based on ERCP Cambridge Criteria. Healthy controls were not analyzed here. | Posted | Count of Participants | Participants | At time of ERCP |
|
|
|
| Secondary | ERCP Cambridge Criteria: Mild | Cambridge Criteria
| The number of participants with "Mild" based on ERCP Cambridge Criteria. | Posted | Count of Participants | Participants | At time of ERCP |
|
|
|
| Secondary | ERCP Cambridge Criteria: Moderate | Cambridge Criteria
| The number of participants with "Moderate" based on ERCP Cambridge Criteria. Healthy controls were not analyzed here. | Posted | Count of Participants | Participants | At time of ERCP |
|
|
|
| Secondary | ERCP Cambridge Criteria: Marked | Cambridge Criteria
| The number of participants with "Marked" based on ERCP Cambridge Criteria. Healthy controls were not analyzed here. | Posted | Count of Participants | Participants | At time of ERCP |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |