Trial Outcomes & Findings for Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management (NCT NCT06068426)

NCT ID: NCT06068426

Last Updated: 2025-07-15

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: At time of EUS procedure
• Results posted on: 2025-07-15

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	45	21
Overall Study COMPLETED	39	20
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

Measure	Children With Confirmed Diagnosis of ARP or CP n=39 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.	Controls (Children Without a History of Pancreatic Disease) n=20 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.	Total n=59 Participants Total of all reporting groups
Age, Continuous	12.13 years n=5 Participants	15.1 years n=7 Participants	13.12 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	9 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	11 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	19 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	39 Participants n=5 Participants • 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.	20 Participants n=7 Participants • 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.	59 Participants n=5 Participants • 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.

PRIMARY outcome

Timeframe: 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).

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)

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=39 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.	Controls (Children Without a History of Pancreatic Disease) n=20 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.
EUS Pancreatic Findings- Rosemont Criteria Lobularity with honeycombing	26 percentage of participants	0 percentage of participants
EUS Pancreatic Findings- Rosemont Criteria Hyperechoic foci without shadowing	49 percentage of participants	15 percentage of participants
EUS Pancreatic Findings- Rosemont Criteria Main pancreatic duct calculi	10 percentage of participants	0 percentage of participants
EUS Pancreatic Findings- Rosemont Criteria Irregular main pancreatic duct contour	49 percentage of participants	0 percentage of participants
EUS Pancreatic Findings- Rosemont Criteria Dilated side branches	10 percentage of participants	0 percentage of participants
EUS Pancreatic Findings- Rosemont Criteria Hyperechoic foci with shadowing	36 percentage of participants	0 percentage of participants
EUS Pancreatic Findings- Rosemont Criteria lobularity without honeycombing	36 percentage of participants	20 percentage of participants
EUS Pancreatic Findings- Rosemont Criteria Cysts	10 percentage of participants	0 percentage of participants
EUS Pancreatic Findings- Rosemont Criteria Stranding	79 percentage of participants	55 percentage of participants
EUS Pancreatic Findings- Rosemont Criteria Main pancreatic duct dilation	15 percentage of participants	0 percentage of participants
EUS Pancreatic Findings- Rosemont Criteria Hyperechoic main pancreatic duct margin	36 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

Capturing weight(kg) and height(cm) to calculate

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=38 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.	Controls (Children Without a History of Pancreatic Disease) n=15 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.
Calculated BMI	21.3 kg/m2 Interval 18.5 to 28.4	30.5 kg/m2 Interval 23.7 to 35.9

SECONDARY outcome

Timeframe: 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.

The presence or absence of recurrence of pancreatitis.

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=39 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.	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.
Acute Recurrent Pancreatitis	10 Participants	—

SECONDARY outcome

Timeframe: 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.

The presence or absence of Chronic pancreatitis diagnosis

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=39 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.	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.
Chronic Pancreatitis	29 Participants	—

SECONDARY outcome

Timeframe: 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.

The presence or absence of exocrine pancreatic insufficiency diagnosis.

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=39 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.	Controls (Children Without a History of Pancreatic Disease) n=20 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.
Exocrine Pancreatic Insufficiency	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

The presence or absence of a diagnosis of diabetes.

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=39 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.	Controls (Children Without a History of Pancreatic Disease) n=20 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.
Diabetes Mellitus	10 Participants	0 Participants

SECONDARY outcome

Timeframe: At time of EUS

Population: The number of subjects without any indications of CP based on Rosemont criteria.

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

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=39 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.	Controls (Children Without a History of Pancreatic Disease) n=20 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.
EUS Rosemont Classification - Normal	6 Participants	19 Participants

SECONDARY outcome

Timeframe: At time of EUS

Population: The number of participants with Indeterminate for CP based on Rosemont Criteria

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

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=39 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.	Controls (Children Without a History of Pancreatic Disease) n=20 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.
EUS Rosemont Classification - Indeterminate for CP	11 Participants	1 Participants

SECONDARY outcome

Timeframe: At time of EUS

Population: The number of participants with "Suggestive of CP" based on Rosemont Criteria.

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

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=39 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.	Controls (Children Without a History of Pancreatic Disease) n=20 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.
EUS Rosemont Classification - Suggestive of CP	12 Participants	0 Participants

SECONDARY outcome

Timeframe: At time of EUS

Population: The number of participants with "Consistent with CP" based on Rosemont Criteria.

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

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=39 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.	Controls (Children Without a History of Pancreatic Disease) n=20 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.
EUS Rosemont Classification - Consistent With CP	10 Participants	0 Participants

SECONDARY outcome

Timeframe: At time of MRI

Population: The number of participants with "Normal" based on MRI Cambridge Grade criteria.

Cambridge Grade:

1. (Normal)

2. (Equivocal)

3. (Mild)

4. (Moderate)

5. (Severe)

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=17 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.	Controls (Children Without a History of Pancreatic Disease) n=2 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.
MRI Cambridge Grade: Normal	4 Participants	2 Participants

SECONDARY outcome

Timeframe: At time of MRI

Population: The number of participants with "Equivocal" based on MRI Cambridge Grade criteria.

Cambridge Grade:

1. (Normal)

2. (Equivocal)

3. (Mild)

4. (Moderate)

5. (Severe)

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=17 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.	Controls (Children Without a History of Pancreatic Disease) n=2 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.
MRI Cambridge Grade: Equivocal	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At time of MRI

Population: The number of participants with "Mild" based on MRI Cambridge Grade criteria.

Cambridge Grade:

1. (Normal)

2. (Equivocal)

3. (Mild)

4. (Moderate)

5. (Severe)

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=17 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.	Controls (Children Without a History of Pancreatic Disease) n=2 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.
MRI Cambridge Grade: Mild	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At time of MRI

Population: The number of participants with "Moderate" based on MRI Cambridge Grade criteria.

Cambridge Grade:

1. (Normal)

2. (Equivocal)

3. (Mild)

4. (Moderate)

5. (Severe)

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=17 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.	Controls (Children Without a History of Pancreatic Disease) n=1 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.
MRI Cambridge Grade: Moderate	5 Participants	0 Participants

SECONDARY outcome

Timeframe: At time of MRI

Population: The number of participants with "Severe" based on MRI Cambridge Grade criteria.

Cambridge Grade:

1. (Normal)

2. (Equivocal)

3. (Mild)

4. (Moderate)

5. (Marked)

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=17 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.	Controls (Children Without a History of Pancreatic Disease) n=2 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.
MRI Cambridge Grade: Severe	8 Participants	0 Participants

SECONDARY outcome

Timeframe: At time of ERCP

Population: The number of participants with "Normal" based on ERCP Cambridge Criteria. Healthy controls were not analyzed here.

Cambridge Criteria

1. (Normal)

2. (Equivocal)

3. (Mild)

4. (Moderate)

5. (Marked)

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=28 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.	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.
ERCP Cambridge Criteria: Normal	0 Participants	—

SECONDARY outcome

Timeframe: At time of ERCP

Population: The number of participants with "Equivocal" based on ERCP Cambridge Criteria. Healthy controls were not analyzed here.

Cambridge Criteria

1. (Normal)

2. (Equivocal)

3. (Mild)

4. (Moderate)

5. (Marked)

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=28 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.	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.
ERCP Cambridge Criteria: Equivocal	4 Participants	—

SECONDARY outcome

Timeframe: At time of ERCP

Population: The number of participants with "Mild" based on ERCP Cambridge Criteria.

Cambridge Criteria

1. (Normal)

2. (Equivocal)

3. (Mild)

4. (Moderate)

5. (Marked)

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=28 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.	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.
ERCP Cambridge Criteria: Mild	1 Participants	—

SECONDARY outcome

Timeframe: At time of ERCP

Population: The number of participants with "Moderate" based on ERCP Cambridge Criteria. Healthy controls were not analyzed here.

Cambridge Criteria

1. (Normal)

2. (Equivocal)

3. (Mild)

4. (Moderate)

5. (Marked)

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=28 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.	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.
ERCP Cambridge Criteria: Moderate	8 Participants	—

SECONDARY outcome

Timeframe: At time of ERCP

Population: The number of participants with "Marked" based on ERCP Cambridge Criteria. Healthy controls were not analyzed here.

Cambridge Criteria

1. (Normal)

2. (Equivocal)

3. (Mild)

4. (Moderate)

5. (Marked)

Outcome measures

Measure	Children With Confirmed Diagnosis of ARP or CP n=28 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.	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.
ERCP Cambridge Criteria: Marked	15 Participants	—

Adverse Events

Children With Confirmed Diagnosis of ARP or CP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls (Children Without a History of Pancreatic Disease)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Vitale

Cincinnati Children's

Phone: (513) 517-7040

Email: David.Vitale@cchmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place