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

Primary Purpose

Chronic Pancreatitis, Acute Recurrent Pancreatitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transabdominal ultrasound Shear wave elastography
Sponsored by
David Vitale MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Pancreatitis

Eligibility Criteria

0 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TUS SWE

Arm Description

This arm includes two cohorts: Children with confirmed diagnosis of ARP or CP Controls (Children without a history of pancreatic disease)

Outcomes

Primary Outcome Measures

EUS Pancreatic findings- 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 Outcome Measures

Calculated BMI
Capturing weight(kg) and height(cm) to calculate
Acute recurrent pancreatitis
Y/N
CP findings
Ductal calculi, dilated side branches, parenchymal calcifications found in any imaging (abdominal ultrasound (abd US), magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP), computerized tomography (CT), endoscopic retrograde cholangiopancreatography (ERCP), endoscopic US (EUS). Ductal obstruction or stricture/dilatation/irregularities that are persistent (for >2 months) on any imaging. Surgical or pancreatic biopsy specimen demonstrating histopathologic features compatible with CP (acinar atrophy, fibrosis, protein plugs, infiltration with lymphocytes, plasma cells, macrophages).
Exocrine pancreatic insufficiency
Y/N
Diabetes medication
Y/N
EUS SWE
Head (Vs m/s) median, IQR, # measurements Genu (Vs m/s) median, IQR, # measurements Body (Vs m/s) median, IQR, # measurements Tail (Vs m/s), median, IQR, # measurements
TUS SWE
Head (Vs m/s) median, IQR, # measurements Body (Vs m/s) median, IQR, # measurements Tail (Vs m/s), median, IQR, # measurements
MRI Findings- Atrophy
(Y/N)
CT Findings- Atrophy
(Y/N)
CT Findings- Calcifications
parenchymal/duct/both/no
CT Findings- Duct Dilation
(Y/N)
CT Findings- Enhancement
hypoenhancing/normal/hyperenhancing/heterogeneous/NA
CT Findings- Acute Pancreatitis
Y/N
ERCP Cambridge findings
- Cambridge Criteria 1 (Normal) 2 (Equivocal) 3 (Mild) 4 (Moderate) 5 (Marked)
Specimen Histology- Fibrosis Score
Four-stage scoring system: 0 = normal pancreas parenchyma, no fibrotic changes; 1 = mild fibrosis with thickening of periductal fibrous tissue; 2 = moderate fibrosis with marked sclerosis of interlobular septa, no evidence of architectural changes, and 3 = severe fibrosis with detection of architectural destruction.
EUS Pancreatic findings- Pancreatic duct size (mm) (include all measured)
Head of pancreas ___ Genu ____ Body ____ Tail ____
EUS Pancreatic findings- Diffuse hyperechogenicity
Y/N
MRI Findings- T1 SIR measurements
Pancreas signal 1 _____ Pancreas signal 2 _____ Pancreas signal 3 _____ Spleen signal 1 _____ Spleen signal 2 _____ Spleen signal 3 _____ Muscle signal 1 _____ Muscle signal 2 _____ Muscle signal 3 _____
MRI Findings- Calculated T1 SIR spleen
(average of 3 pancreas measures)/(average of 3 spleen measures)
MRI Findings- Calculated T1 SIR muscle
(average of 3 pancreas measures)/(average of 3 muscle measures)
MRI Findings- T1 MOLLI
MOLLI 1 _____ MOLLI 2 _____ MOLLI 3 _____
MRI Findings- Enhancement
hypoenhancing/normal/hyperenhancing/heterogeneous/NA
MRI Findings- Cambridge Criteria
1 (Normal) 2 (Equivocal) 3 (Mild) 4 (Moderate) 5 (Marked)
MRI Findings- Pancreas PDFF (%)
PDFF 1 ____ PDFF 2 ____ PDFF 3 ____
MRI Findings- Acute Pancreatitis
Y/N

Full Information

First Posted
June 26, 2023
Last Updated
September 28, 2023
Sponsor
David Vitale MD
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1. Study Identification

Unique Protocol Identification Number
NCT06068426
Brief Title
Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management
Official Title
Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Vitale MD

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis, Acute Recurrent Pancreatitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TUS SWE
Arm Type
Experimental
Arm Description
This arm includes two cohorts: Children with confirmed diagnosis of ARP or CP Controls (Children without a history of pancreatic disease)
Intervention Type
Diagnostic Test
Intervention Name(s)
Transabdominal ultrasound Shear wave elastography
Other Intervention Name(s)
TUS SWE
Intervention Description
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.
Primary Outcome Measure Information:
Title
EUS Pancreatic findings- Rosemont Criteria
Description
- 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
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary Outcome Measure Information:
Title
Calculated BMI
Description
Capturing weight(kg) and height(cm) to calculate
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
Acute recurrent pancreatitis
Description
Y/N
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
CP findings
Description
Ductal calculi, dilated side branches, parenchymal calcifications found in any imaging (abdominal ultrasound (abd US), magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP), computerized tomography (CT), endoscopic retrograde cholangiopancreatography (ERCP), endoscopic US (EUS). Ductal obstruction or stricture/dilatation/irregularities that are persistent (for >2 months) on any imaging. Surgical or pancreatic biopsy specimen demonstrating histopathologic features compatible with CP (acinar atrophy, fibrosis, protein plugs, infiltration with lymphocytes, plasma cells, macrophages).
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
Exocrine pancreatic insufficiency
Description
Y/N
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
Diabetes medication
Description
Y/N
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
EUS SWE
Description
Head (Vs m/s) median, IQR, # measurements Genu (Vs m/s) median, IQR, # measurements Body (Vs m/s) median, IQR, # measurements Tail (Vs m/s), median, IQR, # measurements
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
TUS SWE
Description
Head (Vs m/s) median, IQR, # measurements Body (Vs m/s) median, IQR, # measurements Tail (Vs m/s), median, IQR, # measurements
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
MRI Findings- Atrophy
Description
(Y/N)
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
CT Findings- Atrophy
Description
(Y/N)
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
CT Findings- Calcifications
Description
parenchymal/duct/both/no
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
CT Findings- Duct Dilation
Description
(Y/N)
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
CT Findings- Enhancement
Description
hypoenhancing/normal/hyperenhancing/heterogeneous/NA
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
CT Findings- Acute Pancreatitis
Description
Y/N
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
ERCP Cambridge findings
Description
- Cambridge Criteria 1 (Normal) 2 (Equivocal) 3 (Mild) 4 (Moderate) 5 (Marked)
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
Specimen Histology- Fibrosis Score
Description
Four-stage scoring system: 0 = normal pancreas parenchyma, no fibrotic changes; 1 = mild fibrosis with thickening of periductal fibrous tissue; 2 = moderate fibrosis with marked sclerosis of interlobular septa, no evidence of architectural changes, and 3 = severe fibrosis with detection of architectural destruction.
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
EUS Pancreatic findings- Pancreatic duct size (mm) (include all measured)
Description
Head of pancreas ___ Genu ____ Body ____ Tail ____
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
EUS Pancreatic findings- Diffuse hyperechogenicity
Description
Y/N
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
MRI Findings- T1 SIR measurements
Description
Pancreas signal 1 _____ Pancreas signal 2 _____ Pancreas signal 3 _____ Spleen signal 1 _____ Spleen signal 2 _____ Spleen signal 3 _____ Muscle signal 1 _____ Muscle signal 2 _____ Muscle signal 3 _____
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
MRI Findings- Calculated T1 SIR spleen
Description
(average of 3 pancreas measures)/(average of 3 spleen measures)
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
MRI Findings- Calculated T1 SIR muscle
Description
(average of 3 pancreas measures)/(average of 3 muscle measures)
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
MRI Findings- T1 MOLLI
Description
MOLLI 1 _____ MOLLI 2 _____ MOLLI 3 _____
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
MRI Findings- Enhancement
Description
hypoenhancing/normal/hyperenhancing/heterogeneous/NA
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
MRI Findings- Cambridge Criteria
Description
1 (Normal) 2 (Equivocal) 3 (Mild) 4 (Moderate) 5 (Marked)
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
MRI Findings- Pancreas PDFF (%)
Description
PDFF 1 ____ PDFF 2 ____ PDFF 3 ____
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Title
MRI Findings- Acute Pancreatitis
Description
Y/N
Time Frame
6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 Exclusion criteria: Children <15 kg who cannot accommodate the size of endoscope Children with AP, ARP or CP
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tyler Thompson, BS
Phone
513-517-1055
Email
tyler.thompson@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ethan Estes
Phone
513-803-4322
Email
James.Estes@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Vitale, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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