NCT05410795

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

Same day

First QC Date

June 5, 2022

Last Update Submit

September 13, 2022

Conditions

Keywords

Magnetic resonance imagingPancreatic volume

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Chronic pancreatitis

Patients with chronic pancreatitis are considered as study subjects.

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.

Diagnostic Test: Magnetic resonance imaging

Interventions

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 pancreatitisChronic pancreatitisHealthy people

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients meeting the eligibility criteria.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Pancreatitis, ChronicPancreatitis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Liang-hao Hu, MD

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 5, 2022

First Posted

June 8, 2022

Study Start

September 5, 2022

Primary Completion

September 5, 2022

Study Completion

December 1, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations