Clinical trial NCT06068426: 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
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pancreatitis
Acute Recurrent Pancreatitis
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: EUS Pancreatic findings- Rosemont Criteria
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Secondary outcomes:
measure: Calculated BMI
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: Acute recurrent pancreatitis
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: CP findings
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: Exocrine pancreatic insufficiency
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: Diabetes medication
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: EUS SWE
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: TUS SWE
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: MRI Findings- Atrophy
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: CT Findings- Atrophy
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: CT Findings- Calcifications
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: CT Findings- Duct Dilation
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: CT Findings- Enhancement
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: CT Findings- Acute Pancreatitis
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: ERCP Cambridge findings
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: Specimen Histology- Fibrosis Score
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: EUS Pancreatic findings- Pancreatic duct size (mm) (include all measured)
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: EUS Pancreatic findings- Diffuse hyperechogenicity
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: MRI Findings- T1 SIR measurements
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: MRI Findings- Calculated T1 SIR spleen
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: MRI Findings- Calculated T1 SIR muscle
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: MRI Findings- T1 MOLLI
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: MRI Findings- Enhancement
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: MRI Findings- Cambridge Criteria
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: MRI Findings- Pancreas PDFF (%)
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
measure: MRI Findings- Acute Pancreatitis
timeFrame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: David Vitale, MD
role: PRINCIPAL_INVESTIGATOR
References: