NCT06068426|CompletedResults
Loading search results
Sponsor study identifier
interventional
66
1 country
1
Study Start
September 13, 2021
Actual (reported)Primary Completion
August 4, 2023
Actual (reported)Study Completion
August 4, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 4, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 13, 2021
Actual (reported)June 26, 2023
Actual (reported)August 4, 2023
Actual (reported)August 4, 2023
Actual (reported)October 5, 2023
Actual (reported)July 15, 2025
Actual (reported)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
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)
This arm includes two cohorts: 1. Children with confirmed diagnosis of ARP or CP 2. Controls (Children without a history of pancreatic disease)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
David Vitale, MD
Children's Hospital Medical Center, Cincinnati
66 participants (actual enrollment reported by the registry).
First Submitted
June 26, 2023
First Posted
October 5, 2023
Study Start
September 13, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
August 4, 2023
Actual (reported)Study Completion
August 4, 2023
Actual (reported)Last Updated
July 15, 2025
Results First Posted
July 15, 2025
Record last verified: 2025-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: