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NCT Number: NCT06903676

Utility of Trypsinogen -2 in Early Detection and Follow Up of Post-pancreatectomy Acute Pancreatitis (PPAP)

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.

Recruiting

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Key information

Conditions

Pancreatitis Digestive System Diseases Pancreatectomy Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Nicholas Zyromski, MD

CONTACT

[email protected]

317-944-5012

About this study

Patients will be identified utilizing preoperative scheduling and clinic visits. Patients undergoing any pancreatectomy (such as: pancreatoduodenectomy, distal pancreatectomy, duodenal preserving pancreatic head resection) will be identified. These patients will be educated about possible enrollment in the prospective study in the preoperative clinic or in the surgery preoperative area. If enrolled, these patients will receive the standard of care postoperative laboratory tests. These include, but are not limited to, postoperative serum amylase, drain amylase, complete blood counts, and complete or basic metabolic panels. These patients will have standard of care pathologic review of their operative specimens. These patients will also have their urine tested for TRP-2. This design will allow for the direct comparison of the TRP-2 dipstick tests against the standard of care serum amylase tests. Furthermore, the measuring of serum amylase will allow for the evaluation of post-pancreatectomy acute pancreatitis by the ISGPS definition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRP-2 Urine Dipstick

Device

Urine dipstick testing for Trypsinogen-2

Primary outcomes

  1. Detection of PPAP by Urine Trypsinogen 2

    Time frame: Day of surgery and post-operative days 1, 2 and 3

    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.

  2. Correlation of PPAP diagnosis

    Time frame: Postoperative Day 3

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicholas Zyromski, MD

CONTACT

[email protected]

317-944-5012

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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