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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatitis; Pancreatectomy
• Intervention / Treatment: Device: TRP-2 Urine Dipstick

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicholas Zyromski, MD; Phone Number: 317-944-5012; Email: nzyromski@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Health University Hospital
      • Contact: Nicholas Zyromski, MD; Phone Number: 317-944-5012; Email: nzyromski@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pancreatectomy Patients; Patients who underwent pancreatectomy and are having their urine dipstick tested for Trypsinogen-2	Device: TRP-2 Urine Dipstick; Urine dipstick testing for Trypsinogen-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day of surgery and post-operative days 1, 2 and 3
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.	Postoperative Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative Day 3

Collaborators and Investigators

• Sponsor: Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pancreatectomy; PPAP; Post-pancreatectomy acute pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: 25075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study is not planning to share IPD with other researchers. All IPD will be limited to secure encrypted servers by the institution. Only direct investigators for the study will have access to the IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No