Aim of this study is to investigate the natural course of early peripancreatic collections (i.e. acute fluid collections) in patients with predicted severe AP by CECT and by MRI.
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the amount of solid debris as seen on initial MRI in
relationship to the absorption rate of these collections.
Secondary outcome
• Infectious complications (bacteremia, pneumonia, infected necrosis).
• Length of hospital stay
• Need for ICU admission
• New onset organ failure (onset, extent and duration, see definitions section)
• Length of ICU stay
• Need for percutaneous drainage
• Need for surgical or endoscopical necrosectomy
• Quality of Life.
Background summary
In patients with acute pancreatitis, peripancreatic collections often occur
that either spontaneous resolve or enlarge and become symptomatic. It is
generally acknowledged that CECT is inadequate to discriminate accurately
between collections containing fluid and collections consisting of fluid and
solid debris and that MRI is better suited for making this distinction.
Study objective
Aim of this study is to investigate the natural course of early peripancreatic
collections (i.e. acute fluid collections) in patients with predicted severe AP
by CECT and by MRI.
Study design
A prospective multicenter international study
Study burden and risks
De burden for the patient exists of 2 extra MRI's. These investigations are not
part of everyday practice in patients with acute pancreatitis. However they are
part of everyday practice in a hospital and should not imply an extra risk for
the patient. However every patient that ondergoes the extra MRI scans will be
followed carfully by the attending doctor or by the trial coordinator.
Koekoekslaan 1
Postbus 2500 - 3430 EM Nieuwegein
NL
Koekoekslaan 1
Postbus 2500 - 3430 EM Nieuwegein
NL
Listed location countries
Age
Inclusion criteria
• Age 18 years or above
• Acute pancreatitis: upper abdominal pain and serum lipase and/ or amylase levels 3 times the upper level of normal
• Written informed consent
• Patients with peripancreatic fluid collections on CECT > 3 cm in short axis.
Exclusion criteria
• History or imaging signs of chronic or *acute on chronic* pancreatitis
• AP due to malignancy
• Pregnancy
• Contraindication for MRI imaging (for example pacemaker)
• Incapacitated subjects
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22374.100.08 |