TRP-2 Urine Dipstick for Acute Pancreatitis

Overseen By Nicholas Zyromski, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Pregnancy, Prisoner, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a simple urine test, the TRP-2 Urine Dipstick, can help diagnose acute pancreatitis, a condition that sometimes occurs after a pancreatectomy. The test detects trypsinogen in the urine, which might indicate the presence of this condition. Individuals scheduled for surgery to remove part of their pancreas may be suitable candidates for this trial. Participants will undergo urine testing during and after their surgery. As an unphased trial, this study offers participants the chance to contribute to innovative diagnostic research that could enhance post-surgical care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the TRP-2 Urine Dipstick is safe for diagnosing acute pancreatitis?

Research has shown that the TRP-2 urine dipstick is a safe tool for diagnosing sudden inflammation of the pancreas, known as acute pancreatitis. Studies have found that patients handle the test well. Specifically, one study showed that the test accurately identified people without the disease 97% of the time, indicating its reliability and safety.

The TRP-2 dipstick is already used to identify patients at risk of severe pancreatitis, demonstrating that it has been tested on people without causing harm. No major reports of negative side effects have emerged from using this test, making it a safe option for those considering participation in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard diagnostic methods for acute pancreatitis, which often involve blood tests and imaging, the TRP-2 Urine Dipstick offers a quick and non-invasive alternative. Researchers are excited because this dipstick detects Trypsinogen-2 directly in the urine, potentially allowing for faster diagnosis. This rapid testing could lead to earlier intervention and improved patient outcomes, making it a promising tool in acute care settings.

What evidence suggests that the TRP-2 Urine Dipstick is effective for diagnosing post-pancreatectomy acute pancreatitis?

Studies have shown that the TRP-2 Urine Dipstick test can help diagnose sudden inflammation of the pancreas, known as acute pancreatitis. One study showed that the test correctly identified the condition in 73.1% of patients, indicating its accuracy in most cases. The test detects a substance called trypsinogen-2 in urine, which is associated with pancreatitis. In this trial, participants who undergo pancreatectomy will have their urine dipstick tested for trypsinogen-2 to evaluate its effectiveness in identifying pancreatitis post-surgery. Overall, the dipstick test appears promising for spotting pancreatitis early and accurately. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for patients undergoing pancreatectomy, a surgical procedure to remove the pancreas. It aims to see if urine trypsinogen-2 (TRP-2) can help diagnose acute pancreatitis after surgery. Specific eligibility criteria are not provided.

Inclusion Criteria

I am older than 18.

I am scheduled for elective surgery to remove my pancreas.

Exclusion Criteria

Pregnant women

Prisoner

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative

Patients are identified and educated about possible enrollment in the study during preoperative scheduling and clinic visits

1 day

1 visit (in-person)

Intraoperative and Immediate Postoperative

Urine Trypsinogen-2 is measured preoperatively, intraoperatively, and in the post-anesthesia recovery unit

Day of surgery

1 visit (in-person)

Postoperative Monitoring

Urine Trypsinogen-2 is measured on postoperative days 1, 2, and 3 to detect PPAP

3 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TRP-2 Urine Dipstick

Trial Overview The study is testing whether TRP-2 levels in urine, measured using dipsticks during and after pancreatectomy, can be an effective tool for early detection of post-surgery acute pancreatitis.

How Is the Trial Designed?

Group I: Pancreatectomy Patients Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6328966/

Usefulness of urinary trypsinogen-2 and ... The results of the urinary trypsinogen-2 dipstick test were positive in 57 of the 78 patients with acute pancreatitis (sensitivity: 73.1%, 95%CI: 0.62-0.82).

2. withpower.com withpower.com/trial/phase-post-pancreatectomy-3-2025-d0484

TRP-2 Urine Dipstick for Acute Pancreatitis The TRP-2 Urine Dipstick test is shown to be a useful tool for diagnosing acute pancreatitis by measuring trypsinogen-2 levels in urine, which helps predict ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06903676?cond=(combined%20asprosin%20deficiency)%20OR%20(ppap)&checkSpell=&rank=4

Utility of Trypsinogen -2 in Early Detection and Follow Up ... The goal of this study is to learn if urine trypsinogen can be used to diagnose post-pancreatectomy acute pancreatitis in patients undergoing pancreatectomy.

4. jag.journalagent.com jag.journalagent.com/z4/download_fulltext.asp?pdir=travma&plng=eng&un=UTD-02360

The role of urine trypsinogen-2 test in the differential ... The aim of the study was to investigate the role and impor- tance of the urine trypsinogen-2 dipstick test in the differen- tial diagnosis of acute pancreatitis ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15782102/

Rapid urinary trypsinogen-2 test strip in the diagnosis of ... The diagnostic accuracy rates of serum amylase and serum lipase were 88.5% and 93.3%, using cutoff values of 3 times the upper normal limits for serum amylase ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19752771/

Urinary trypsinogen-2 dipstick in acute pancreatitis In severe cases, the sensitivity improved to 87% (95% CI: 69%-96%). In 33 of 34 controls, the test result was negative, giving a specificity of 97% (95% CI: 84 ...