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

NCT06903676 | Recruiting FDA Device

• 1 other identifier: 25075
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatectomy; Pancreatitis

Keywords

Pancreatectomy; Post-pancreatectomy acute pancreatitis; PPAP

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Pancreatectomy Patients

EXPERIMENTAL

Patients who underwent pancreatectomy and are having their urine dipstick tested for Trypsinogen-2

Device: TRP-2 Urine Dipstick

Interventions

TRP-2 Urine Dipstick DEVICE

Urine dipstick testing for Trypsinogen-2

Pancreatectomy Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years of age
• Undergoing elective pancreatectomy for any indication

You may not qualify if:

• Younger than 18 years of age
• Pregnant women
• Prisoner

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Nicholas Zyromski, MD

CONTACT

317-944-5012; nzyromski@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: August 5, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)