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

NCT03098082 | Completed Results FDA Device

• 1 other identifier: 1701950933
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

Brief 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 determine the test characteristics (sensitivity and specificity) of the UTDT for the diagnosis of PEP: Hypotheses:

1. 1.UTDT is a sensitive and specific test for the diagnosis of PEP for patients undergoing ERCP.
2. 2.At a cutpoint for a negative test of \<50ug/L, UTDT will be accurate at 2 hours post ERCP in patients whose baseline test is negative.

Conditions

Post-ERCP Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of Urine Trypsinogen-2 Dipstick Testing for the Diagnosis of Post-ERCP Pancreatitis

  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 diagnosis by consensus criteria 2. True negative: negative dipstick testing, no diagnosis of post ERCP pancreatitis by consensus criteria 3. False positive: positive urine dipstick test, no diagnosis of post-ERCP pancreatitis by consensus criteria 4. False negative: negative urine dipstick test. diagnosis of post-ERCP pancreatitis by consensus criteria

  Urine dipstick testing assessed 2-3 hours following ERCP, for post ERCP pancreaitits.

Study Arms (1)

Actim Pancreatitis Dipstick Test

OTHER

All enrolled subjects who meet inclusion/exclusion criteria will have the Urine Trypsinogen 2 Dipstick test done.

Device: Actim Pancreatitis

Interventions

Actim Pancreatitis DEVICE

Actim Pancreatitis (Medix Biochemica) is a urine trypsinogen-2 dipstick test (UTDT) that uses trypsinogen-2 as a biomarker for acute pancreatitis.

Actim Pancreatitis Dipstick Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of Age
• Undergoing Outpatient ERCP

You may not qualify if:

• Unwillingness or inability to consent for the study
• Acute pancreatitis on presentation or within 1 month
• Recent ERCP (i.e. within 1 month)
• Amylase or Lipase elevation greater than 2 x upper limit of normal within 7 days prior to ERCP
• Stage 3 or 4 renal disease and/or oliguria
• Inability to access the ampulla at ERCP attempt (e.g. gastric outlet obstruction)
• Unable to provide baseline urine sample

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Limitations and Caveats

Did not meet enrollment goal for the study (goal 1825 subjects)

Results Point of Contact

• Title: Jeffrey J. Easler, MD
• Organization: Indiana University School of Medicine

jjeasler@iu.edu

3179440980

Study Officials

• Jeffrey Easler, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Cares providers, patients and study primary investigators will be blinded to 2 hour Urine Trypsinogen dip stick test results. Results will not be released or posted on subject chart.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: All enrolled subjects who meet study inclusion /exclusion will have the Urine Trypsinogen dip stick test

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 31, 2017
• Study Start: July 6, 2017
• Primary Completion: April 8, 2020
• Study Completion: April 8, 2020
• Last Updated: June 26, 2023
• Results First Posted: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)