Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03098082 · ClinicalTrials.gov registry record · NA
Urine Trypsinogen 2 Dipstick for the Early Detection of Post-ERCP Pancreatitis
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 394
- Enrollment target
NCT03098082 is a NA study that has completed, run by Indiana University. The registered enrollment target is 394 participants.
The verdict
NCT03098082, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 394 participants
- Enrollment target
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
Interventions
- DEVICE Actim Pancreatitis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 394 participants |
| Start Date | 2017-07-06 |
| Est. Completion | 2020-04-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03098082
The ClinicalTrials.gov registry entry for NCT03098082 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 394 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Actim Pancreatitis is the first listed.
NCT03098082 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03098082 about?
NCT03098082 is a clinical study titled "Urine Trypsinogen 2 Dipstick for the Early Detection of Post-ERCP Pancreatitis". 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 expendit...
What is the current status of trial NCT03098082?
This trial is currently completed. It is a NA study. The enrollment target is 394 participants. The study started on 2017-07-06. Estimated completion is 2020-04-08.
What interventions are being tested in trial NCT03098082?
The interventions under investigation include: Actim Pancreatitis (DEVICE).
Who is sponsoring clinical trial NCT03098082?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.