Chronic PancreatitisNCT06068426
Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management
A study testing Transabdominal ultrasound Shear wave elastography in people with Chronic Pancreatitis and Acute Recurrent Pancreatitis, run by David Vitale MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis, Acute Recurrent Pancreatitis
- What is being tested?
- Transabdominal ultrasound Shear wave elastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2021to 4 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
- Children without a history of pancreatic disease undergoing EUS for other clinical indications
- ≤ 21 years of age, male and female
Who cannot join
- Children <15 kg who cannot accommodate the size of endoscope
- Children with acute pancreatitis (AP) <6 weeks prior to EUS
- Control Cohort:
- Children <15 kg who cannot accommodate the size of endoscope
- Children with AP, ARP or CP
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
Read the detailed description
The aims of the proposed study are as follows:
Aim 1: Characterize endoscopic ultrasound (EUS) findings of pediatric acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP).
Adult criteria for EUS diagnosis of CP exist, but no such criteria exist for children. As such, the applicability of current diagnostic criteria to pediatric patients is unknown.
1.1: Catalogue grayscale EUS findings of ARP and CP in a pediatric cohort and compare to healthy controls. Hypothesis: EUS findings of ARP and CP in pediatric patients will differ from those of adult ARP and CP and will be characteristically different from healthy controls. Exp1: We will catalogue grayscale EUS findings in 40 pediatric
patients with known history of ARP or CP undergoing clinically indicated EUS and will compare those with findings in 20 patients without a history of pancreatitis who are undergoing EUS for other indications.
1.2: Benchmark grayscale EUS against other imaging modalities for diagnosis of CP, particularly early CP, in children. Hypothesis: Grayscale EUS findings will be more sensitive than other imaging modalities in all stages of CP. Exp2: We will test associations, in blinded fashion, of grayscale EUS findings catalogued under S.A1.1 in enrolled children with findings on alternative pancreas imaging modalities performed for clinical indications. Specifically, we will correlate to endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP) and computed tomography (CT) performed for clinical indications within +/- 3 months of the EUS.
Aim 2: Define the diagnostic performance of ultrasound elastography for CP and pancreatic stiffness as a measure of fibrosis in pediatric patients.
2.1: Define the diagnostic performance of EUS and TUS elastography for pediatric CP. Hypothesis: EUS and TUS elastography will have high specificity for CP with increased stiffness in patients compared to controls. Exp 1: Patients enrolled under Aim 1 will undergo shear wave elastography (SWE) measurement of the pancreas during EUS. These same patients will undergo research TUS with SWE of the pancreas. SWE results by both EUS and TUS will be evaluated for diagnostic performance for CP.
2.2: Define agreement between EUS and TUS measurement of pancreatic parenchymal stiffness in pediatric patients. Hypothesis: EUS and TUS measures of pancreatic parenchymal stiffness will agree with minimal bias. Exp2: EUS and TUS SWE data obtained under S.A2.1 will be evaluated for agreement and divergent cases will be investigated to define causes.
2.3: Define the diagnostic performance of elastography for pancreatic fibrosis. Hypothesis: SWE is a sensitive indicator of pancreatic fibrosis as identified by histology. Exp3: Patients undergoing clinically indicated total pancreatectomy and islet auto transplant (TPIAT) or other pancreatic surgical resection at our institution (approximately 20 per year) will be approached to undergo pre-operative TUS SWE. These SWE measurements, along with EUS SWE measurements obtained preoperatively, will be compared to binary and semi-quantitative assessments of pancreatic parenchymal fibrosis by histology.
- Conditions
- Chronic Pancreatitis, Acute Recurrent Pancreatitis
- Being tested
- Transabdominal ultrasound Shear wave elastography
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal ultrasound Shear wave elastographyDiagnostic test
Also called TUS SWE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Transabdominal ultrasound Shear wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At time of EUS procedure
Secondary outcomes (19)
Calculated BMI
Capturing weight(kg) and height(cm) to calculate
Measured: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Acute Recurrent Pancreatitis
The presence or absence of recurrence of pancreatitis.
Measured: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Chronic Pancreatitis
The presence or absence of Chronic pancreatitis diagnosis
Measured: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Exocrine Pancreatic Insufficiency
The presence or absence of exocrine pancreatic insufficiency diagnosis.
Measured: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Diabetes Mellitus
The presence or absence of a diagnosis of diabetes.
Measured: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
EUS Rosemont Classification - Normal
The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification.
Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin
Measured: At time of EUS
EUS Rosemont Classification - Indeterminate for CP
The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification.
Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin
Measured: At time of EUS
EUS Rosemont Classification - Suggestive of CP
The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification.
Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin
Measured: At time of EUS
EUS Rosemont Classification - Consistent With CP
The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification.
Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin
Measured: At time of EUS
MRI Cambridge Grade: Normal
Cambridge Grade:
- (Normal)
- (Equivocal)
- (Mild)
- (Moderate)
- (Severe)
Measured: At time of MRI
MRI Cambridge Grade: Equivocal
Cambridge Grade:
- (Normal)
- (Equivocal)
- (Mild)
- (Moderate)
- (Severe)
Measured: At time of MRI
MRI Cambridge Grade: Mild
Cambridge Grade:
- (Normal)
- (Equivocal)
- (Mild)
- (Moderate)
- (Severe)
Measured: At time of MRI
MRI Cambridge Grade: Moderate
Cambridge Grade:
- (Normal)
- (Equivocal)
- (Mild)
- (Moderate)
- (Severe)
Measured: At time of MRI
MRI Cambridge Grade: Severe
Cambridge Grade:
- (Normal)
- (Equivocal)
- (Mild)
- (Moderate)
- (Marked)
Measured: At time of MRI
ERCP Cambridge Criteria: Normal
Cambridge Criteria
- (Normal)
- (Equivocal)
- (Mild)
- (Moderate)
- (Marked)
Measured: At time of ERCP
ERCP Cambridge Criteria: Equivocal
Cambridge Criteria
- (Normal)
- (Equivocal)
- (Mild)
- (Moderate)
- (Marked)
Measured: At time of ERCP
ERCP Cambridge Criteria: Mild
Cambridge Criteria
- (Normal)
- (Equivocal)
- (Mild)
- (Moderate)
- (Marked)
Measured: At time of ERCP
ERCP Cambridge Criteria: Moderate
Cambridge Criteria
- (Normal)
- (Equivocal)
- (Mild)
- (Moderate)
- (Marked)
Measured: At time of ERCP
ERCP Cambridge Criteria: Marked
Cambridge Criteria
- (Normal)
- (Equivocal)
- (Mild)
- (Moderate)
- (Marked)
Measured: At time of ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start13 Sep 2021
- Primary completion4 Aug 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Vitale MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Vitale MD, Children's Hospital Medical Center, Cincinnati
- Investigators
- David Vitale, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068426
- Sponsor's protocol ID
- 2021-0499
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2023
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management
- ClinicalTrials.gov ID
- NCT06068426
- Acronym / sponsor ID
- 2021-0499
- Conditions
- Chronic Pancreatitis, Acute Recurrent Pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- David Vitale MDUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Posted 15 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aims of the proposed study are as follows:
Aim 1: Characterize endoscopic ultrasound (EUS) findings of pediatric acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP).
Adult criteria for EUS diagnosis of CP exist, but no such criteria exist for children. As such, the applicability of current diagnostic criteria to pediatric patients is unknown.
1.1: Catalogue grayscale EUS findings of ARP and CP in a pediatric cohort and compare to healthy controls. Hypothesis: EUS findings of ARP and CP in pediatric patients will differ from those of adult ARP and CP and will be characteristically different from healthy controls. Exp1: We will catalogue grayscale EUS findings in 40 pediatric
patients with known history of ARP or CP undergoing clinically indicated EUS and will compare those with findings in 20 patients without a history of pancreatitis who are undergoing EUS for other indications.
1.2: Benchmark grayscale EUS against other imaging modalities for diagnosis of CP, particularly early CP, in children. Hypothesis: Grayscale EUS findings will be more sensitive than other imaging modalities in all stages of CP. Exp2: We will test associations, in blinded fashion, of grayscale EUS findings catalogued under S.A1.1 in enrolled children with findings on alternative pancreas imaging modalities performed for clinical indications. Specifically, we will correlate to endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP) and computed tomography (CT) performed for clinical indications within +/- 3 months of the EUS.
Aim 2: Define the diagnostic performance of ultrasound elastography for CP and pancreatic stiffness as a measure of fibrosis in pediatric patients.
2.1: Define the diagnostic performance of EUS and TUS elastography for pediatric CP. Hypothesis: EUS and TUS elastography will have high specificity for CP with increased stiffness in patients compared to controls. Exp 1: Patients enrolled under Aim 1 will undergo shear wave elastography (SWE) measurement of the pancreas during EUS. These same patients will undergo research TUS with SWE of the pancreas. SWE results by both EUS and TUS will be evaluated for diagnostic performance for CP.
2.2: Define agreement between EUS and TUS measurement of pancreatic parenchymal stiffness in pediatric patients. Hypothesis: EUS and TUS measures of pancreatic parenchymal stiffness will agree with minimal bias. Exp2: EUS and TUS SWE data obtained under S.A2.1 will be evaluated for agreement and divergent cases will be investigated to define causes.
2.3: Define the diagnostic performance of elastography for pancreatic fibrosis. Hypothesis: SWE is a sensitive indicator of pancreatic fibrosis as identified by histology. Exp3: Patients undergoing clinically indicated total pancreatectomy and islet auto transplant (TPIAT) or other pancreatic surgical resection at our institution (approximately 20 per year) will be approached to undergo pre-operative TUS SWE. These SWE measurements, along with EUS SWE measurements obtained preoperatively, will be compared to binary and semi-quantitative assessments of pancreatic parenchymal fibrosis by histology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TUS SWE | Experimental | Diagnostic Test: Transabdominal ultrasound Shear wave elastographyThis arm includes two cohorts: 1. Children with confirmed diagnosis of ARP or CP 2. Controls (Children without a history of pancreatic disease) |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
- Children without a history of pancreatic disease undergoing EUS for other clinical indications
Key exclusion criteria (5 listed)
- Children <15 kg who cannot accommodate the size of endoscope
- Children with acute pancreatitis (AP) <6 weeks prior to EUS
- Children <15 kg who cannot accommodate the size of endoscope
- Children with AP, ARP or CP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transabdominal ultrasound Shear wave elastographyAlso: TUS SWETUS 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. | Diagnostic test | TUS SWE |
Primary outcome
EUS Pancreatic Findings- Rosemont Criteria
Time frame: At time of EUS procedure
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)
19 secondary outcomes
Calculated BMI
Time frame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Acute Recurrent Pancreatitis
Time frame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Chronic Pancreatitis
Time frame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Exocrine Pancreatic Insufficiency
Time frame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
Diabetes Mellitus
Time frame: 6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)
EUS Rosemont Classification - Normal
Time frame: At time of EUS
EUS Rosemont Classification - Indeterminate for CP
Time frame: At time of EUS
EUS Rosemont Classification - Suggestive of CP
Time frame: At time of EUS
EUS Rosemont Classification - Consistent With CP
Time frame: At time of EUS
MRI Cambridge Grade: Normal
Time frame: At time of MRI
MRI Cambridge Grade: Equivocal
Time frame: At time of MRI
MRI Cambridge Grade: Mild
Time frame: At time of MRI
MRI Cambridge Grade: Moderate
Time frame: At time of MRI
MRI Cambridge Grade: Severe
Time frame: At time of MRI
ERCP Cambridge Criteria: Normal
Time frame: At time of ERCP
ERCP Cambridge Criteria: Equivocal
Time frame: At time of ERCP
ERCP Cambridge Criteria: Mild
Time frame: At time of ERCP
ERCP Cambridge Criteria: Moderate
Time frame: At time of ERCP
ERCP Cambridge Criteria: Marked
Time frame: At time of ERCP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Vitale, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transabdominal ultrasound Shear wave elastography in people with Chronic Pancreatitis and Acute Recurrent Pancreatitis, run by David Vitale MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EUS Pancreatic Findings- Rosemont Criteria (time frame: At time of EUS procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.