Trial Outcomes & Findings for Urine Trypsinogen 2 Dipstick for the Early Detection of Post-ERCP Pancreatitis (NCT NCT03098082)
NCT ID: NCT03098082
Last Updated: 2023-06-26
Results Overview
The urine Trypsinogen result will be codified as positive (indicative of a urine level cutpoint \>50ug/L) or negative for post ERCP pancreatitis (indicative of a urine cutpoint level of \<50ug/L) . This will be measured against the consensus criteria diagnosis for post ERCP pancreatitis (admission for abdominal pain symptoms of pancreatitis and serum amylase or lipase \>3 times the upper limit of normal at 24 hours after ERCP). 1. True positive: Positive dipstick, post ERCP pancreatitis diagnosis by consensus criteria 2. True negative: negative dipstick testing, no diagnosis of post ERCP pancreatitis by consensus criteria 3. False positive: positive urine dipstick test, no diagnosis of post-ERCP pancreatitis by consensus criteria 4. False negative: negative urine dipstick test. diagnosis of post-ERCP pancreatitis by consensus criteria
COMPLETED
NA
394 participants
Urine dipstick testing assessed 2-3 hours following ERCP, for post ERCP pancreaitits.
2023-06-26
Participant Flow
Participant milestones
| Measure |
Actim Pancreatitis Dipstick Test
All enrolled subjects who meet inclusion/exclusion criteria will have the Urine Trypsinogen 2 Dipstick test done.
Actim Pancreatitis: Actim Pancreatitis (Medix Biochemica) is a urine trypsinogen-2 dipstick test (UTDT) that uses trypsinogen-2 as a biomarker for acute pancreatitis.
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|---|---|
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Overall Study
STARTED
|
394
|
|
Overall Study
COMPLETED
|
254
|
|
Overall Study
NOT COMPLETED
|
140
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Urine Trypsinogen 2 Dipstick for the Early Detection of Post-ERCP Pancreatitis
Baseline characteristics by cohort
| Measure |
Actim Pancreatitis Dipstick Test
n=254 Participants
All enrolled subjects who meet inclusion/exclusion criteria will have the Urine Trypsinogen 2 Dipstick test done.
Actim Pancreatitis: Actim Pancreatitis (Medix Biochemica) is a urine trypsinogen-2 dipstick test (UTDT) that uses trypsinogen-2 as a biomarker for acute pancreatitis.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
242 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Indication for ERCP
Biliary
|
167 Participants
n=5 Participants
|
|
Indication for ERCP
Pancreatic
|
61 Participants
n=5 Participants
|
|
Indication for ERCP
Biliary and Pancreatic
|
26 Participants
n=5 Participants
|
|
Reported Pre-ERCP abdominal pain
|
119 Participants
n=5 Participants
|
|
Reported Post-ERCP abdominal pain
|
129 Participants
n=5 Participants
|
|
Post-ERCP pancreatitis
|
9 Participants
n=5 Participants
|
|
Pre-ERCP UTDT positivity
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Urine dipstick testing assessed 2-3 hours following ERCP, for post ERCP pancreaitits.The urine Trypsinogen result will be codified as positive (indicative of a urine level cutpoint \>50ug/L) or negative for post ERCP pancreatitis (indicative of a urine cutpoint level of \<50ug/L) . This will be measured against the consensus criteria diagnosis for post ERCP pancreatitis (admission for abdominal pain symptoms of pancreatitis and serum amylase or lipase \>3 times the upper limit of normal at 24 hours after ERCP). 1. True positive: Positive dipstick, post ERCP pancreatitis diagnosis by consensus criteria 2. True negative: negative dipstick testing, no diagnosis of post ERCP pancreatitis by consensus criteria 3. False positive: positive urine dipstick test, no diagnosis of post-ERCP pancreatitis by consensus criteria 4. False negative: negative urine dipstick test. diagnosis of post-ERCP pancreatitis by consensus criteria
Outcome measures
| Measure |
Actim Pancreatitis Dipstick Test
n=254 Participants
All enrolled subjects who meet inclusion/exclusion criteria will have the Urine Trypsinogen 2 Dipstick test done.
Actim Pancreatitis: Actim Pancreatitis (Medix Biochemica) is a urine trypsinogen-2 dipstick test (UTDT) that uses trypsinogen-2 as a biomarker for acute pancreatitis.
|
|---|---|
|
Sensitivity and Specificity of Urine Trypsinogen-2 Dipstick Testing for the Diagnosis of Post-ERCP Pancreatitis
Sensitivity (%)
|
11.1 percentage of participants
Interval 7.25 to 14.98
|
|
Sensitivity and Specificity of Urine Trypsinogen-2 Dipstick Testing for the Diagnosis of Post-ERCP Pancreatitis
Specificity (%)
|
91 percentage of participants
Interval 87.5 to 94.54
|
|
Sensitivity and Specificity of Urine Trypsinogen-2 Dipstick Testing for the Diagnosis of Post-ERCP Pancreatitis
Positive Predictive Value (%)
|
4.4 percentage of participants
Interval 1.84 to 6.86
|
|
Sensitivity and Specificity of Urine Trypsinogen-2 Dipstick Testing for the Diagnosis of Post-ERCP Pancreatitis
Negative Predictive Value
|
96.5 percentage of participants
Interval 94.29 to 98.79
|
Adverse Events
Actim Pancreatitis Dipstick Test
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeffrey J. Easler, MD
Indiana University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place