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

NCT06068426 | Completed Results

• 1 other identifier: 2021-0499
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pancreatitis; Acute Recurrent Pancreatitis

Outcome Measures

Primary Outcomes (1)

• EUS Pancreatic Findings- Rosemont Criteria

  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)

  At time of EUS procedure

Secondary Outcomes (19)

• Calculated BMI

  6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)

• Acute Recurrent Pancreatitis

  6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)

• Chronic Pancreatitis

  6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)

• Exocrine Pancreatic Insufficiency

  6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)

• Diabetes Mellitus

  6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)

Study Arms (1)

TUS SWE

EXPERIMENTAL

This arm includes two cohorts: 1. Children with confirmed diagnosis of ARP or CP 2. Controls (Children without a history of pancreatic disease)

Diagnostic Test: Transabdominal ultrasound Shear wave elastography

Interventions

Transabdominal ultrasound Shear wave elastography DIAGNOSTIC_TEST

TUS SWE will be performed using a Canon Aplio i800 ultrasound system and a curved 1-6 MHz transducer. 2D SWE will be performed with measurement of shear wave speed in the head, body and tail of the pancreas.

Also known as: TUS SWE

TUS SWE

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Children \<15 kg who cannot accommodate the size of endoscope
• Children with acute pancreatitis (AP) \<6 weeks prior to EUS
• Control Cohort:
• Children without a history of pancreatic disease undergoing EUS for other clinical indications
• ≤ 21 years of age, male and female
• Children \<15 kg who cannot accommodate the size of endoscope
• Children with AP, ARP or CP

Sponsors & Collaborators

• David Vitale MD: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. David Vitale
• Organization: Cincinnati Children's

David.Vitale@cchmc.org

(513) 517-7040

Study Officials

• David Vitale, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: October 5, 2023
• Study Start: September 13, 2021
• Primary Completion: August 4, 2023
• Study Completion: August 4, 2023
• Last Updated: July 15, 2025
• Results First Posted: July 15, 2025

Record last verified: 2025-06

Locations

US (1)