Use of urine trypsinogen-2 to detect acute pancreatitis after pancreatectomy
Utility of Trypsinogen -2 in Early Detection and Follow Up of Post-pancreatectomy Acute Pancreatitis (PPAP)
We will test whether a urine trypsinogen-2 dipstick can detect post-pancreatectomy acute pancreatitis in adults having elective pancreatectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06903676 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for any elective pancreatectomy at Indiana University Health will be prospectively enrolled during preoperative clinic or scheduling visits. Enrolled patients will receive standard postoperative laboratory tests (including serum and drain amylase, blood counts, and metabolic panels) while also having urine tested for trypsinogen-2 with a dipstick during and after surgery. TRP-2 dipstick results will be compared directly to serum amylase and to the ISGPS definition of post-pancreatectomy acute pancreatitis. This parallel measurement approach tests whether a rapid, noninvasive urine marker can identify PPAP alongside standard care.
Who should consider this trial
Good fit: Adults over 18 undergoing elective pancreatectomy for any indication who can give informed consent are appropriate candidates for this protocol.
Not a fit: Patients under 18, pregnant women, and prisoners are excluded and would not be eligible to receive benefit from participation.
Why it matters
Potential benefit: If successful, a urine TRP-2 dipstick could provide faster, noninvasive detection of post-pancreatectomy acute pancreatitis and enable earlier management after pancreatectomy.
How similar studies have performed: Urine trypsinogen-2 has shown promise as a noninvasive marker for acute pancreatitis in other settings, but its specific use for post-pancreatectomy acute pancreatitis is relatively novel and less well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Older than 18 years of age * Undergoing elective pancreatectomy for any indication Exclusion Criteria: * Younger than 18 years of age * Pregnant women * Prisoner
Where this trial is running
Indianapolis, Indiana
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Nicholas Zyromski, MD
- Email: nzyromski@iu.edu
- Phone: 317-944-5012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.