NCT03456557

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 7, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2018

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

February 22, 2018

Last Update Submit

April 10, 2020

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Relation between CT perfusion calculated k-trans and clinicobiological SIRS score in early phase of acute pancreatitis.

    admission day

Study Arms (1)

Computed tomography.

EXPERIMENTAL
Radiation: Perfusion computed tomography.

Interventions

Perfusion computed tomography.RADIATION

Using specific post treatment imaging software ( Olea® ) we will calculatell permeability parameters : the pancreatic blood flow and the k-trans, capillary membrane permeability factor.

Computed tomography.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with acute pancreatitis (based on the Atlanta definition).

You may not qualify if:

  • Patient under 18 yearras old
  • Contraindication of injection of iodinated contrast medium
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Cytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 7, 2018

Study Start

March 7, 2018

Primary Completion

December 9, 2018

Study Completion

December 9, 2018

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations

FR(1)