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

Indiana University

Status: Enrolling

Conditions: Pancreatitis; Pancreatectomy

Treatments: Device: TRP-2 Urine Dipstick

Study type: Interventional

Funder types: Other

Identifiers

NCT06903676

25075

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Pancreatectomy Patients

Experimental group

Description:

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

Treatment:

Device: TRP-2 Urine Dipstick