Establishment and Verification of Pancreatic Volume Formula Based on Imaging

Chronic Pancreatitis Clinical Trial

Official title:

Establishment and Verification of Pancreatic Volume Formula Based on Imaging: A Cross-sectional Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05410795
• Other study ID #: EPIC20220428
• Status: Enrolling by invitation
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Chronic Pancreatitis
• Healthy People
• Pancreatitis
• Pancreatitis, Chronic

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