N/A
N=66
Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management
Chronic Pancreatitis · Acute Recurrent Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT06068426 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: EUS Pancreatic Findings- Rosemont Criteria — 36; 0; 26; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transabdominal ultrasound Shear wave elastography (Diagnostic_test)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- David Vitale MD
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY EUS Pancreatic Findings- Rosemont Criteria |
36; 0; 26; 0; 36; 20 | — |
| SECONDARY Calculated BMI |
21.3; 30.5 | — |
| SECONDARY Acute Recurrent Pancreatitis |
10 | — |
| SECONDARY Chronic Pancreatitis |
29 | — |
| SECONDARY Exocrine Pancreatic Insufficiency |
2; 0 | — |
| SECONDARY Diabetes Mellitus |
10; 0 | — |
| SECONDARY EUS Rosemont Classification - Normal |
6; 19 | — |
| SECONDARY EUS Rosemont Classification - Indeterminate for CP |
11; 1 | — |
| SECONDARY EUS Rosemont Classification - Suggestive of CP |
12; 0 | — |
| SECONDARY EUS Rosemont Classification - Consistent With CP |
10; 0 | — |
| SECONDARY MRI Cambridge Grade: Normal |
4; 2 | — |
| SECONDARY MRI Cambridge Grade: Equivocal |
0; 0 | — |
| SECONDARY MRI Cambridge Grade: Mild |
0; 0 | — |
| SECONDARY MRI Cambridge Grade: Moderate |
5; 0 | — |
| SECONDARY MRI Cambridge Grade: Severe |
8; 0 | — |
| SECONDARY ERCP Cambridge Criteria: Normal |
— | — |
| SECONDARY ERCP Cambridge Criteria: Equivocal |
4 | — |
| SECONDARY ERCP Cambridge Criteria: Mild |
1 | — |
| SECONDARY ERCP Cambridge Criteria: Moderate |
8 | — |
| SECONDARY ERCP Cambridge Criteria: Marked |
15 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT06068426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.