Healthy PeopleNCT05410795
Establishment and Verification of Pancreatic Volume Formula Based on Imaging
An observational study of Healthy People and Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
Trial summary
This study intends to construct the linear relationship between pancreatic volume and individual attributes (height, weight, width of anterior superior iliac spine, etc.), and to establish and verify the formula of pancreatic volume. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Healthy People, Chronic Pancreatitis, Acute Pancreatitis
- What is being tested?
- Magnetic resonance imaging
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2022to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: Inpatients meeting the eligibility criteria.
Who may be able to join
- Healthy individuals (excluding pancreatic related diseases, such as acute and chronic pancreatitis, pancreatic trauma, pancreatic tumor, peripancreatic lesions, diabetes and other diseases that may affect the volume of the pancreas);
- Patients with chronic pancreatitis;
- Patients with acute pancreatitis within 144 hours after the onset of typical symptoms (severe persistent epigastric pain).
Who cannot join
- suspected to have malignant tumors;
- History of pancreas related surgery or minimally invasive treatment (such as pancreaticoduodenectomy, ERCP, etc.);
- acute exacerbation of chronic pancreatitis;
- pregnant or breastfeeding women;
- patients who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishment and Verification of Pancreatic Volume Formula Based on Imaging: A Cross-sectional Study
This study intends to construct the linear relationship between pancreatic volume and individual attributes (height, weight, width of anterior superior iliac spine, etc.), and to establish and verify the formula of pancreatic volume.
Read the detailed description
The volume of pancreas in healthy individuals changes with age. The pancreatic volume gradually increases from birth to 20 years old. There is a plateau period from 20 to 60 years old, and the volume gradually decreases after 60 years old. With the development of imaging technology, pancreatic volume can be measured by computer tomography and magnetic resonance imaging.
Whether it is pancreatic atrophy after chronic pancreatitis or pancreatic edema after acute pancreatitis, the pathological changes of pancreatic parenchyma may lead to changes in pancreatic volume. Many studies have confirmed that pancreatic volume can be used to evaluate the course of pancreatic related diseases such as diabetes and acute pancreatitis.
Therefore, the establishment of accurate and convenient pancreatic volume formula can help to estimate the initial pancreatic volume of patients. This study is helpful to evaluate the clinical stage, severity and prognosis of pancreatic related diseases.
- Conditions
- Healthy People, Chronic Pancreatitis, Acute Pancreatitis
- Being tested
- Magnetic resonance imaging
- Keywords
- Magnetic resonance imaging, Pancreatic volume
- Medical subject headings
- Pancreatitis, Chronic, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDiagnostic test
Enrolled subjects will be examined with MRI of pancreas, and the volume, length and thickness of coronal plane of pancreas will be measured by software.
| Study group | Role | What they receive |
|---|---|---|
| Healthy people | Healthy people refer to those who exclude pancreatic related diseases, such as acute and chronic pancreatitis, pancreatic trauma, pancreatic tumor, peripancreatic lesions, diabetes and other diseases that may affect the volume of the pancreas. Receives: Diagnostic Test: Magnetic resonance imaging | |
| Chronic pancreatitis | Patients with chronic pancreatitis are considered as study subjects. Receives: Diagnostic Test: Magnetic resonance imaging | |
| Acute pancreatitis | Patients with acute pancreatitis within 144 hours after the onset of typical symptoms are considered as study subjects. Receives: Diagnostic Test: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic volume
The total volume of pancreas and the volumes of head, body and tail of pancreas will be calculated by software.
Measured: 14 days after MRI examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start5 Sep 2022
- Primary completion5 Sep 2022
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PeopleStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Liang-hao Hu, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410795
- Sponsor's protocol ID
- EPIC20220428
- Status last verified
- Sep 2022
- First submitted
- 5 Jun 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Verification of Pancreatic Volume Formula Based on Imaging: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05410795
- Acronym / sponsor ID
- EPIC20220428
- Conditions
- Healthy People, Chronic Pancreatitis, Acute Pancreatitis
- Keywords
- Magnetic resonance imaging, Pancreatic volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to construct the linear relationship between pancreatic volume and individual attributes (height, weight, width of anterior superior iliac spine, etc.), and to establish and verify the formula of pancreatic volume.
Detailed description
The volume of pancreas in healthy individuals changes with age. The pancreatic volume gradually increases from birth to 20 years old. There is a plateau period from 20 to 60 years old, and the volume gradually decreases after 60 years old. With the development of imaging technology, pancreatic volume can be measured by computer tomography and magnetic resonance imaging.
Whether it is pancreatic atrophy after chronic pancreatitis or pancreatic edema after acute pancreatitis, the pathological changes of pancreatic parenchyma may lead to changes in pancreatic volume. Many studies have confirmed that pancreatic volume can be used to evaluate the course of pancreatic related diseases such as diabetes and acute pancreatitis.
Therefore, the establishment of accurate and convenient pancreatic volume formula can help to estimate the initial pancreatic volume of patients. This study is helpful to evaluate the clinical stage, severity and prognosis of pancreatic related diseases.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy people | – | Diagnostic Test: Magnetic resonance imagingHealthy people refer to those who exclude pancreatic related diseases, such as acute and chronic pancreatitis, pancreatic trauma, pancreatic tumor, peripancreatic lesions, diabetes and other diseases that may affect the volume of the pancreas. |
| Chronic pancreatitis | – | Diagnostic Test: Magnetic resonance imagingPatients with chronic pancreatitis are considered as study subjects. |
| Acute pancreatitis | – | Diagnostic Test: Magnetic resonance imagingPatients with acute pancreatitis within 144 hours after the onset of typical symptoms are considered as study subjects. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Inpatients meeting the eligibility criteria.
Key inclusion criteria (3 listed)
- Healthy individuals (excluding pancreatic related diseases, such as acute and chronic pancreatitis, pancreatic trauma, pancreatic tumor, peripancreatic lesions, diabetes and other diseases that may affect the volume of the pancreas);
- Patients with chronic pancreatitis;
- Patients with acute pancreatitis within 144 hours after the onset of typical symptoms (severe persistent epigastric pain).
Key exclusion criteria (5 listed)
- suspected to have malignant tumors;
- History of pancreas related surgery or minimally invasive treatment (such as pancreaticoduodenectomy, ERCP, etc.);
- acute exacerbation of chronic pancreatitis;
- pregnant or breastfeeding women;
- patients who refused to participate in the study.
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 |
|---|---|---|
| Magnetic resonance imagingEnrolled subjects will be examined with MRI of pancreas, and the volume, length and thickness of coronal plane of pancreas will be measured by software. | Diagnostic test | Acute pancreatitis, Chronic pancreatitis, Healthy people |
Primary outcome
Pancreatic volume
Time frame: 14 days after MRI examination
The total volume of pancreas and the volumes of head, body and tail of pancreas will be calculated by software.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Liang-hao Hu, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy People and Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. 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 China. 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?
Results are not available in the source record.
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?
Pancreatic volume (time frame: 14 days after MRI examination). 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 14 Sep 2022.