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

Urinary Trypsinogen-2 for Detecting Pancreatitis After Pancreas Surgery

N
Nicholas Zyromski, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
50 participants needed
1 Location

Brief description of study

To evaluate the ability of urinary trypsinogen-2 to identify post pancreatectomy acute pancreatitis during the operative and immediate postoperative period. Earlier identification of PPAP will allow for close monitoring and possible early intervention for these patient's during their post operative recovery.

Patients will be recruited from the patient group undergoing pancreatectomy at IU University hospital. These patient's will be prospectively identified by reviewing the schedule of Dr. Nicholas Zyromski. All patients undergoing pancreatectomy will be offered the chance to enroll in the study. Patients will not be specifically selected for or against. These patients will be contacted the morning of their surgery at University hospital in the pre-Operative area. A discussion of the goals of the project, what it entails for the patients, and any risks for the patient will be completed.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

2.1 Primary Objective
To determine whether urine trypsinogen 2, measured intraoperatively, can provide early diagnosis of PPAP

2.2 Secondary Objective
To correlate PPAP diagnosis by TRP-2 with PPAP diagnosed by the ISGPS definition.

2.3 Tertiary/Exploratory/Correlative Objective To correlate acinar cell concentrations at the pancreatectomy edge with TRP-2 measurements.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cancer, Post-Pancreatectomy Acute Pancreatitis, PPAP
  • Age: 18 years - 100 years
  • Gender: All

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

Exclusion Criteria
•    Pregnant women

Updated on 08 Sep 2025. Study ID: SURG-IIR-TRYSINOGEN, 25075

This study investigates the use of urinary trypsinogen-2 to detect post-pancreatectomy acute pancreatitis (PPAP). Pancreatectomy is a surgery to remove part or all of the pancreas. PPAP is a condition that can occur after this surgery, where the pancreas becomes inflamed. The purpose of this study is to see if measuring trypsinogen-2 in urine can help identify PPAP early, allowing for better monitoring and care of patients after their surgery.

Participants will have their urine tested for trypsinogen-2 during and after their surgery. Trypsinogen-2 is a substance that can be measured to see if the pancreas is inflamed. The study will compare these test results with other methods of diagnosing PPAP to see how well they agree.

  • Who can participate: Adults over 18 years old who are having a planned pancreatectomy can participate. Pregnant women are not eligible.
  • Study details: Participants will have urine samples collected during their surgery to measure trypsinogen-2 levels. This is to see if it can detect pancreatitis early. The study will also compare these results with other diagnosis methods.
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only