Utility of Trypsinogen -2 in Early Detection and Follow Up of Post-pancreatectomy Acute Pancreatitis (PPAP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
The goal of this study is to learn if urine trypsinogen can be used to diagnose post-pancreatectomy acute pancreatitis in patients undergoing pancreatectomy.
Participants will have their urine measured by dipsticks during and after their surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Older than 18 years of age
Undergoing elective pancreatectomy for any indication
Disqualifiers
Younger than 18 years of age
Pregnant women
Prisoner
Trial design
Design model
Single group
Treatments tested in this trial
TRP-2 Urine Dipstick
DeviceUrine dipstick testing for Trypsinogen-2
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Pancreatectomy PatientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Detection of PPAP by Urine Trypsinogen 2
TRP-2 will be measured in freshly obtained urine preoperatively as a control, intraoperatively at time of pancreas transection, in the post anesthesia recovery unit, and in the morning of POD 1-3. This will be measured by the Actim Pancreatitis urine dipstick test. This will be compared to standard of care serum amylase tests.
Time frame
Day of surgery and post-operative days 1, 2 and 32
Correlation of PPAP diagnosis
PPAP diagnosis by Urine Trypsinogen 2 will be correlated with PPAP diagnosed by the International Study Group for Pancreatic Surgery (ISGPS) definition. PPAP, as defined by the ISGPS, requires (1) a sustained postoperative serum hyperamylasemia greater than the upper limit of normal for at least the first 48 hours postoperatively, (2) clinically relevant features, and (3) radiologic alterations consistent with PPAP.
Time frame
Postoperative Day 3Sponsors and contacts
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Source ClinicalTrials.gov