Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pancreatitis; Acute Recurrent Pancreatitis
• Intervention / Treatment: Diagnostic test: Transabdominal ultrasound Shear wave elastography

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion criteria:

• Children <15 kg who cannot accommodate the size of endoscope
• Children with AP, ARP or CP

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TUS SWE; This arm includes two cohorts: Children with confirmed diagnosis of ARP or CP; Controls (Children without a history of pancreatic disease)	Diagnostic test: 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.; Other Names: TUS SWE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	At time of EUS procedure

Secondary Outcome Measures

Outcome Measure	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.	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: (Normal); (Equivocal); (Mild); (Moderate); (Severe)	At time of MRI
MRI Cambridge Grade: Equivocal	Cambridge Grade: (Normal); (Equivocal); (Mild); (Moderate); (Severe)	At time of MRI
MRI Cambridge Grade: Mild	Cambridge Grade: (Normal); (Equivocal); (Mild); (Moderate); (Severe)	At time of MRI
MRI Cambridge Grade: Moderate	Cambridge Grade: (Normal); (Equivocal); (Mild); (Moderate); (Severe)	At time of MRI
MRI Cambridge Grade: Severe	Cambridge Grade: (Normal); (Equivocal); (Mild); (Moderate); (Marked)	At time of MRI
ERCP Cambridge Criteria: Normal	Cambridge Criteria; (Normal); (Equivocal); (Mild); (Moderate); (Marked)	At time of ERCP
ERCP Cambridge Criteria: Equivocal	Cambridge Criteria; (Normal); (Equivocal); (Mild); (Moderate); (Marked)	At time of ERCP
ERCP Cambridge Criteria: Mild	Cambridge Criteria; (Normal); (Equivocal); (Mild); (Moderate); (Marked)	At time of ERCP
ERCP Cambridge Criteria: Moderate	Cambridge Criteria; (Normal); (Equivocal); (Mild); (Moderate); (Marked)	At time of ERCP
ERCP Cambridge Criteria: Marked	Cambridge Criteria; (Normal); (Equivocal); (Mild); (Moderate); (Marked)	At time of ERCP

Collaborators and Investigators

• Sponsor: David Vitale MD
• Investigators: Principal Investigator: David Vitale, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): August 4, 2023
• Study Completion (Actual): August 4, 2023

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: 2021-0499

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No