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

NCT ID: NCT06903676

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2026-04-30

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.

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.

Conditions

Pancreatitis; Pancreatectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pancreatectomy Patients

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

Group Type: EXPERIMENTAL

TRP-2 Urine Dipstick

Intervention Type: DEVICE

Urine dipstick testing for Trypsinogen-2

Interventions

TRP-2 Urine Dipstick

Urine dipstick testing for Trypsinogen-2

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Nicholas J Zyromski

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicholas Zyromski, MD

Role: CONTACT

nzyromski@iu.edu

317-944-5012

Facility Contacts

Nicholas Zyromski, MD

Role: primary

nzyromski@iu.edu

317-944-5012

Other Identifiers

25075

Identifier Type: -

Identifier Source: org_study_id