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Ultrasound + Elastography for Pediatric Pancreatitis
N/A
Recruiting
Led By David Vitale, MD
Research Sponsored by David Vitale MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≤ 21 years of age, male and female
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Awards & highlights
No Placebo-Only Group
Summary
This trial is researching pancreatic diseases in children & using ultrasound & elastography to measure fibrosis & diagnose these diseases.
Who is the study for?
This trial is for children up to 21 years old with confirmed acute recurrent or chronic pancreatitis. It includes those undergoing endoscopic ultrasound (EUS) for their care, and specifically some who are having pancreatic surgery.
What is being tested?
The study tests how well transabdominal and endoscopic ultrasound elastography can measure scarring in the pancreas of pediatric patients. This could improve diagnosis and management of childhood pancreatitis.
What are the potential side effects?
Since this trial involves diagnostic procedures rather than medications, side effects may include discomfort during the ultrasound procedure or potential risks associated with EUS.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
EUS Pancreatic findings- Rosemont Criteria
Secondary study objectives
Acute recurrent pancreatitis
CP findings
CT Findings- Acute Pancreatitis
+22 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TUS SWEExperimental Treatment1 Intervention
This arm includes two cohorts:
1. Children with confirmed diagnosis of ARP or CP
2. Controls (Children without a history of pancreatic disease)
Find a Location
Who is running the clinical trial?
David Vitale MDLead Sponsor
1 Previous Clinical Trials
192 Total Patients Enrolled
David Vitale, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
1 Previous Clinical Trials
192 Total Patients Enrolled