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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

Study 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.Check my eligibility

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.See study design

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 below

Select...

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

EUS Pancreatic findings- Rosemont Criteria

Secondary outcome measures

Acute recurrent pancreatitis

CP findings

CT Findings- Acute Pancreatitis

+22 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TUS SWEExperimental Treatment1 Intervention

This arm includes two cohorts: Children with confirmed diagnosis of ARP or CP Controls (Children without a history of pancreatic disease)

0 / 1Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is inclusion in the trial limited to adults younger than 45 years old?

"Prospective enrollees must be between 0 and 21 years of age, in accordance with the trial's inclusion criteria."

Answered by AI

Is participation in this research open to me?

"This medical trial is centred around individuals with chronic pancreatitis who are between infancy and 21 years old. Requiring approximately 60 participants, the study has opened enrolment to those that meet its criteria."

Answered by AI

Are there any available openings for participants in this clinical trial?

"Clinicaltrials.gov confirms that this medical trial, first made public on September 13th 2021, is actively recruiting participants. The most recent updates were posted on the 28th of September 2023."

Answered by AI

What is the total number of participants for this research project?

"Affirmative. Clinicaltrials.gov reflects that this investigation, which was originally posted on September 13th 2021, is presently searching for participants. 60 individuals are being welcomed at one location to partake in the test."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management

David Vitale MD 2021. "Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06068426.

All > Chronic Pancreatitis