Establishment and Verification of Pancreatic Volume Formula Based on Imaging

Sponsor
Changhai Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05410795
Collaborator
(none)
300
1
2
149.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Magnetic resonance imaging

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

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Establishment and Verification of Pancreatic Volume Formula Based on Imaging: A Cross-sectional Study
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Chronic pancreatitis

Patients with chronic pancreatitis are considered as study subjects.

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.

Acute pancreatitis

Patients with acute pancreatitis within 144 hours after the onset of typical symptoms are considered as study subjects.

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.

Outcome Measures

Primary Outcome Measures

  1. Pancreatic volume [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changhai Hospital Shanghai China 200433

Sponsors and Collaborators

  • Changhai Hospital

Investigators

  • Principal Investigator: Liang-hao Hu, MD, Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhaoshen Li, Professor, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT05410795
Other Study ID Numbers:
  • EPIC20220428
First Posted:
Jun 8, 2022
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhaoshen Li, Professor, Changhai Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2022