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ID
Source
Brief title
Health condition
Post-ERCP pancreatitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Asses the sensitivity and specificity of an ERCP discharge tool that combines a discharge algorithm and urinary trypsinogen-2 dipstick.
Secondary outcome
1) Endoscopist and patient attitudes (measured by PREM questionnaire) towards discharge tool combined with urinary dipstick testing.
2) Identification of factors that lead to false positives and negatives of the trypsinogen-2 urinary dipstick.
3) Overall cost reduction obtained by safe early discharge.
Background summary
The most commonly occurring complication of an endoscopic retrograde cholangiopancreaticography (ERCP) is that of the post-ERCP pancreatitis (PEP), with an incidence of 3.5%-9.7%. Approximately 90% of the cases have a mild to moderately severity, although there is still a chance of 1-3% mortality in this group of patients. There is little consensus on which patients are merited by a longer observation period post-procedural, which results in a large variance between hospitals of those who are admitted post-ERCP. Most patients can be discharged under guidance after 2 hours of recovery, but it is essential to identify the patients at high risk for complications such as PEP.
Research question: What is the added value of an urinary trypsinogen-2 dipstick to an already established ERCP discharge tool by Jeurnink et al.?
Objective: To evaluate the ERCP discharge tool in combination with a urinary trypsinogen-2 dipstick test in the early identification of patients at risk for developing a post-ERCP pancreatitis.
Study objective
ERCP discharge algorithm combined with UT-2 dipstick test (with a cutoff value of 50µg/ml) can accurately distinguish between groups warranting early discharge and those warranting observation post-ERCP.
Study design
Primary: 2 hours after ERCP
Secondary: Day 0- 5 days after ERCP or until discharge
Intervention
Urine dipstick 2 hours after scope-mouth contact of ERCP + patient reported experience measurement at day of discharge
Inclusion criteria
- Patients undergoing ERCP
- Age >18 years
Exclusion criteria
- Ongoing acute pancreatitis
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8486 |
| Other | CMO Radboudumc : 2018-4431 |