to investigate the course of the pancreatic enzymes (serum amylase, serum lipase and urinary amylase) related to the course and stage of acute pancreatitis and thereby calculating the diagnostic accuracy of each pancreatic enzyme for acute…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal inflammatory conditions
Synonym
Health condition
pancreasontstekingsaandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The diagnostic accuracy (AUC/ROC) of serum amylase, serum lipase and urinary
amylase for acute pancreatitis per day after onset of symptoms until day 5 and
on day 7.
Secondary outcome
- difference in diagnostic accuracy (AUC/ROC) after subgroup analyses:
different etiology of acute pancreatitis (f.e. alcohol induced, hyperlipidemia
induced or biliary acute pancreatitis), and mild versus severe pancreatitis
- difference in diagnostic accuracy (AUC/ROC) in urinary amylase versus amylase
creatinine clearance ratio
- difference in diagnostic accuracy (AUC/ROC) in one solitary pancreatic enzyme
versus a combination of enzymes
Background summary
Acute pancreatitis is a common problem and a potentially fatal disease.
Diagnosing acute pancreatitis is difficult due to the lack of a gold standard.
The value of pancreatic enzyme measurement in acute pancreatitis has been
debated abundantly in the last century. Nevertheless there are still
limitations in using these enzymes in making the diagnosis acute pancreatitis.
Study objective
to investigate the course of the pancreatic enzymes (serum amylase, serum
lipase and urinary amylase) related to the course and stage of acute
pancreatitis and thereby calculating the diagnostic accuracy of each pancreatic
enzyme for acute pancreatitis per day until day 5 and on day 7 after onset of
symptoms.
Study design
Prospective single centre study
Study burden and risks
Daily collection of blood until day 5 and on day 7 after onset of symptoms is
part of regular patient care in admitted patients. Extra urine portions will be
collected daily. If patients are discharged within this period patients will be
asked to collect urine and have blood withdrawal at the hospital. Collection of
urine and blood withdrawal is without risk and of limited burden.
If not already done for diagnostic reasons, an extra contrast enhaced CT in all
patients will be performed. There is a low risk for radiation-related secondary
cancer development (lifetime attributable risk 0,05%). Contrast may cause
allergy or nefrotoxicity (patients with chronic kidney disease will be
excluded).
Lijnbaan 32
Den Haag 3512 VA
NL
Lijnbaan 32
Den Haag 3512 VA
NL
Listed location countries
Age
Inclusion criteria
- hospitalized patients with acute onset of persistent, severe, epigastric pain
- aged *18 years
- able to provide written informed consent
Exclusion criteria
complaints starting more than 7 days before admission
chronic kidney disease (MDRD < 30ml/min)
pregnancy (serum beta hCG < 5U/l)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46840.098.14 |