The diagnostic performance of different diagnostic tests to detect post-ERCP pancreatitis: trypsinogen-2 urinary dipstick test and serum trypsinogen-2, amylase, lipase and a prediction model

ERCP is generally followed by overnight observation for potential
complications. However, more than 90% of patients do not develop complications
and do not need the overnight stay. Several serum and urine markers have been
tested for prediction of early diagnosis and severity of pancreatitis. Serum
trypsinogen-2 and the urinary trypsinogene-2 dipstick test (UTDT) have been
evaluated to diagnose pancreatitis in emergency settings and seem to be
accurate diagnostic tests. In addition, the dipstick test is easy in use
without any burden to the patient. The serum test has the potential advantage
that it provides a continuous outcome, which might say something about severity
of the pancreatitis. Other serum markers have been tested for prediction of
early diagnosis and severity of pancreatitis as well. Serum markers, like
lipase and amylase (with various cut-off points) can be considered as an early
diagnostic test. A drawback of serum amylase and lipase is that these markers
peak in nearly every patient between 1.5-4 hours post ERCP. The swiftness and
degree of the elevation, however, can be an indicator for patients developing
PEP.
Another way to predict the occurrence of post-ERCP pancreatitis is by a risk
model based on patient - and procedure related factors. A risk model has been
designed to select patients at high and low risks for complications, such as
post-ERCP pancreatitis (PEP). This model was designed in another center and
will be tested on accuracy of prediction of development of post ERCP
pancreatitis in our medical center.
A comparison of serum and urinary trypsinogen-2 tests, serum amylase and a
prediction model to evaluate the most accurate predictor of post-ERCP
pancreatitis has not yet been performed. futhermore, both models will be
compared for agreement and to detect the most accurate model. Detecting the
most accurate, early diagnostic test and cut-off point can (in the future)
help selecting patients eligible for early discharge after ERCP.

Primary objective:
- To evaluate the diagnostic performance of the urinary trypsinogen-2 test for
post-ERCP pancreatitis
Secondary objectives:
- To evaluate the diagnostic performance of serum trypsinogen-2, serum
amylase/lipase for post-ERCP pancreatitis
- To identify other patient- and procedure related risk factors for post-ERCP
pancreatitis
- To create a multivariate model with independent predictors for post-ERCP
pancreatitis
- To evaluate the performance of existing prediction model (designed in
Rotterdam) for post-ERCP pancreatitis
- To compare the existing prediction model to our multivariate model.

Prospective, observational study.
Urine and blood samples (2*9 ml) will be collected before and 2 hours after
ERCP. Blood samples collected before ERCP are part of routine patient care. A
risk score will be calculated after ERCP based on patient and procedure
related risk factors. The treating physician will be kept blind for the test
results.
Minor complications (nausea, pain and discomfort) will be measured (according
to standardized questionnaires) 2 hours and 24 hours after ERCP. All patienst
will admitted for overnight observation.
On day 7 and 30 patients are contacted by telephone to evaluate complications,
symptoms, additional use of medication, hospital admission or visits to the
general practitioner (according to standardized questionnaires).

Risks: the risk of drawing a blood sample is negligible.

Burden: Urine and blood samples (2*9 ml) will be collected before and 2 hours
after ERCP. Blood samples collected before ERCP are part of routine patient
care. Minor complications (nausea, pain and discomfort) will be measured
(according to standardized questionnaires) 2 hours and 24 hours after ERCP. On
day 7 and 30 patients are contacted by telephone to evaluate complications,
symptoms, additional use of medication, hospital admission or visits to the
general practitioner (according to standardized questionnaires).

Benefit: For the subjects partcipating in the study: none
For the general population undergoing ERCP: Various diagnostic tests are
examined to safely discharge outpatient ERCP patients, which hopefully leads to
a more progressive and safe discharge strategy.