Urine Trypsinogen 2 Dipstick for the Early Detection of Post-ERCP Pancreatitis

Study Summary

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common, serious complication of ERCP. More than 500,000 ERCP procedures are performed from which 25,000 cases of PEP occur in the U.S.A. annually. PEP accounts for significant morbidity and health care expenditures. While symptoms of PEP arise immediately after ERCP, they are non-specific. Consequently, unnecessary admissions of outpatients without PEP and inadvertent discharge of outpatients with PEP from ERCP recovery are common. An accurate, confirmatory test for diagnosis of PEP immediately after ERCP is lacking. Actim Pancreatitis (Medix Biochemica) is a urine trypsinogen-2 dipstick test (UTDT) that uses trypsinogen-2 as a biomarker for acute pancreatitis. Urine Trypisinogen-2 Dipstick test (UTDT) is a simple, inexpensive test with promising preliminary data for accuracy for immediate diagnosis of PEP. Prior studies of ITDT test characteristics lack rigorous scientific design. Investigators will enroll 1825 ERCP outpatients at our institution in a prospective cohort study. A pre-ERCP UTDT test and diagnostic UTDT 2 hours after the ERCP will be performed. Patients with a positive baseline UTDT will be followed clinically as part of this study without 2 hour testing. Care providers and study primary investigators will be blinded to the 2 hour UTDT results. Baseline, intra-procedure and recovery room clinical data will be recorded. Diagnosis of PEP will be made blinded to the UTDT result. Admission status for PEP will be assessed by review of records and phone/e-mail contact 5 days and 30 days after ERCP procedure. Sensitivity and specificity of 2 hour post ERCP UTDT for the diagnosis of PEP will be calculated. Aims: 1) To determine the test characteristics of UTDT for the diagnosis of PEP 2 hours after completion of ERCP. 2) To identify and describe patients with baseline UTDT positivity, in whom this test offers limited utility. Specific Aims: Primary Aim 1.1 To determin

Primary Outcome

The urine Trypsinogen result will be codified as positive (indicative of a urine level cutpoint \>50ug/L) or negative for post ERCP pancreatitis (indicative of a urine cutpoint level of \<50ug/L) . This will be measured against the consensus criteria diagnosis for post ERCP pancreatitis (admission for abdominal pain symptoms of pancreatitis and serum amylase or lipase \>3 times the upper limit of normal at 24 hours after ERCP). 1. True positive: Positive dipstick, post ERCP pancreatitis diagnos

Interventions

• DEVICE Actim Pancreatitis