Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06068426
Status:
RECRUITING
Last Update Posted:
2023-10-05
First Post:
2023-06-26
Brief Title:
Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management
Sponsor:
David Vitale MD
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
11 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
12 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 SA11 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
21 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
22 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 SA21 will be evaluated for agreement and divergent cases will be investigated to define causes
23 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
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
11 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
12 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 SA11 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
21 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
22 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 SA21 will be evaluated for agreement and divergent cases will be investigated to define causes
23 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None