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

Chronic Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068426
• Other study ID #: 2021-0499
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: September 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Tyler Thompson, BS
• Phone: 513-517-1055
• Email: tyler.thompson[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Recurrent Pancreatitis
• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
David Vitale MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	Calculated BMI	Capturing weight(kg) and height(cm) to calculate	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	Acute recurrent pancreatitis	Y/N	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	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).	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	Exocrine pancreatic insufficiency	Y/N	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	Diabetes medication	Y/N	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	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	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	TUS SWE	Head (Vs m/s) median, IQR, # measurements; Body (Vs m/s) median, IQR, # measurements; Tail (Vs m/s), median, IQR, # measurements	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	MRI Findings- Atrophy	(Y/N)	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	CT Findings- Atrophy	(Y/N)	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	CT Findings- Calcifications	parenchymal/duct/both/no	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	CT Findings- Duct Dilation	(Y/N)	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	CT Findings- Enhancement	hypoenhancing/normal/hyperenhancing/heterogeneous/NA	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	CT Findings- Acute Pancreatitis	Y/N	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	ERCP Cambridge findings	- Cambridge Criteria; 1 (Normal); 2 (Equivocal); 3 (Mild); 4 (Moderate); 5 (Marked)	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	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.	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	EUS Pancreatic findings- Pancreatic duct size (mm) (include all measured)	Head of pancreas ___; Genu ____; Body ____; Tail ____	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	EUS Pancreatic findings- Diffuse hyperechogenicity	Y/N	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	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 _____	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	MRI Findings- Calculated T1 SIR spleen	(average of 3 pancreas measures)/(average of 3 spleen measures)	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	MRI Findings- Calculated T1 SIR muscle	(average of 3 pancreas measures)/(average of 3 muscle measures)	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	MRI Findings- T1 MOLLI	MOLLI 1 _____; MOLLI 2 _____; MOLLI 3 _____	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	MRI Findings- Enhancement	hypoenhancing/normal/hyperenhancing/heterogeneous/NA	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	MRI Findings- Cambridge Criteria	1 (Normal); 2 (Equivocal); 3 (Mild); 4 (Moderate); 5 (Marked)	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	MRI Findings- Pancreas PDFF (%)	PDFF 1 ____; PDFF 2 ____; PDFF 3 ____	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary	MRI Findings- Acute Pancreatitis	Y/N	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)