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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05410795
Other study ID # EPIC20220428
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 5, 2022
Est. completion date December 2022

Study information

Verified date September 2022
Source Changhai Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 300
Est. completion date December 2022
Est. primary completion date September 5, 2022
Accepts healthy volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria (Meet 1 or 2 or 3): - 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). Exclusion Criteria: - 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.

Study Design


Intervention

Diagnostic Test:
Magnetic resonance imaging
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.

Locations

Country Name City State
China Changhai Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pancreatic volume The total volume of pancreas and the volumes of head, body and tail of pancreas will be calculated by software. 14 days after MRI examination
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