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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098082
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Easler, Indiana University

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. UTDT is a sensitive and specific test for the diagnosis of PEP for patients undergoing ERCP.
  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.

Condition or disease Intervention/treatment Phase
Post-ERCP Acute Pancreatitis Device: Actim Pancreatitis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1825 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All enrolled subjects who meet study inclusion /exclusion will have the Urine Trypsinogen dip stick test
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Diagnostic
Official Title: Urine Trypsinogen 2 Dipstick for the Early Detection of Post-ERCP Pancreatitis
Actual Study Start Date : July 6, 2017
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Actim Pancreatitis Dipstick Test
All enrolled subjects who meet inclusion/exclusion criteria will have the Urine Trypsinogen 2 Dipstick test done.
Device: Actim Pancreatitis
Actim Pancreatitis (Medix Biochemica) is a urine trypsinogen-2 dipstick test (UTDT) that uses trypsinogen-2 as a biomarker for acute pancreatitis.




Primary Outcome Measures :
  1. Sensitivity and specificity of urine Trypsinogen-2 dipstick testing for the diagnosis of post-ERCP pancreatitis [ Time Frame: Urine dipstick testing assessed 2-3 hours following ERCP, for post ERCP pancreaitits. ]

    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of Age
  2. Undergoing Outpatient ERCP

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098082


Contacts
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Contact: Jeffrey Easler, MD 317-948-4978 jjeasler@iu.edu
Contact: Suzette Schmidt, RN 317-948-8104 suschmid@iu.edu

Locations
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United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Suzette Schmidt, RN    317-948-8104    suschmid@iu.edu   
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Jeffrey Easler, MD Indiana University
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Responsible Party: Jeffrey Easler, Assistant Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03098082    
Other Study ID Numbers: 1701950933
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases