Improving management of pancreatitis in children using advanced imaging techniques
Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management
This study is testing new imaging techniques to see if they can help doctors better understand and treat pancreatitis in children.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 0 Years to 21 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06068426 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the understanding and treatment of acute recurrent pancreatitis and chronic pancreatitis in children by utilizing endoscopic ultrasound (EUS) and shear wave elastography (SWE). The research will catalog EUS findings in pediatric patients and compare them to healthy controls to establish diagnostic criteria specific to children. Additionally, the study will benchmark EUS against other imaging modalities to assess its sensitivity in diagnosing chronic pancreatitis at various stages. By including both affected children and healthy controls, the study seeks to provide a comprehensive analysis of pancreatic conditions in the pediatric population.
Who should consider this trial
Good fit: Ideal candidates include children aged 21 years or younger with a confirmed diagnosis of acute recurrent pancreatitis or chronic pancreatitis.
Not a fit: Patients with acute pancreatitis occurring less than six weeks prior to the endoscopic ultrasound may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic criteria and treatment strategies for children suffering from pancreatitis.
How similar studies have performed: While studies have shown success in using EUS and SWE for adult pancreatitis, this approach in children is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: David Vitale, MD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Tyler Thompson, BS
- Email: tyler.thompson@cchmc.org
- Phone: 513-517-1055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.