Back to resultsThe Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score (K-PA)
Primary Purpose
Acute Pancreatitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Perfusion computed tomography.
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- Patient with acute pancreatitis (based on the Atlanta definition).
Exclusion Criteria:
- Patient under 18 yearras old
- Contraindication of injection of iodinated contrast medium
- Pregnancy
Sites / Locations
- Chu de Poitiers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Computed tomography.
Arm Description
Outcomes
Primary Outcome Measures
Relation between CT perfusion calculated k-trans and clinicobiological SIRS score in early phase of acute pancreatitis.
Secondary Outcome Measures
Full Information
NCT ID
NCT03456557
First Posted
February 22, 2018
Last Updated
April 10, 2020
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03456557
Brief Title
The Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score
Acronym
K-PA
Official Title
The Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
December 9, 2018 (Actual)
Study Completion Date
December 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators to establish whether early microvascular permeability parameter evaluated by perfusion-CT could be good biomarkers for severity in acute pancreatitis.
Therefore the investigators want to compare 48 hours-clinico-biological systemic inflammatory response syndrome score to initial microvascular permeability parameters ( ktrans - capillary membrane permeability factor- and pancreatic blood flow ) calculated by OLEA software using inclusion perfusion CT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computed tomography.
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Perfusion computed tomography.
Intervention Description
Using specific post treatment imaging software ( Olea® ) we will calculatell permeability parameters : the pancreatic blood flow and the k-trans, capillary membrane permeability factor.
Primary Outcome Measure Information:
Title
Relation between CT perfusion calculated k-trans and clinicobiological SIRS score in early phase of acute pancreatitis.
Time Frame
admission day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with acute pancreatitis (based on the Atlanta definition).
Exclusion Criteria:
Patient under 18 yearras old
Contraindication of injection of iodinated contrast medium
Pregnancy
Facility Information:
Facility Name
Chu de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Learn more about this trial
The Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score
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