Chronic Pancreatitis Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
David Vitale MD |
United States,
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) |
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