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Recruiting NCT06903676

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

No phase Interventional Pancreatitis Pancreatectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRP-2 Urine Dipstick.
Who it may be relevant to
Registry conditions: Pancreatitis, Pancreatectomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device TRP-2 Urine Dipstick
    Urine dipstick testing for Trypsinogen-2

Primary outcome measures

  • Detection of PPAP by Urine Trypsinogen 2 [Time frame: Day of surgery and post-operative days 1, 2 and 3]
  • Correlation of PPAP diagnosis [Time frame: Postoperative Day 3]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Indiana University Health University Hospital — Indianapolis

Identifiers

NCT: NCT06903676 · 25075

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗