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Prevention study for Post-ERCP Acute Pancreatitis
Official title Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis
ClinicalTrials.gov ID: NCT06260878
What this study is testing
- What it's testing
- This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients \>75 years of age)
- ability to give informed consent
- native major papillary anatomy
- ability and willingness to obtain bloodwork the day after ERCP
You likely can't join if
- prior ERCP with sphincterotomy and/or sphincteroplasty
- confirmed or suspected cholangitis or sepsis
- confirmed pancreatitis, hyperlipasemia, or hyperamylasemia within the preceding 7 days
- NYHA Class II or greater heart failure
- active pulmonary edema
- myocardial infarction or ischemia within the preceding 3 months
See the full eligibility criteria
- age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients \>75 years of age)
- ability to give informed consent
- native major papillary anatomy
- ability and willingness to obtain bloodwork the day after ERCP
- prior ERCP with sphincterotomy and/or sphincteroplasty
- confirmed or suspected cholangitis or sepsis
- confirmed pancreatitis, hyperlipasemia, or hyperamylasemia within the preceding 7 days
- NYHA Class II or greater heart failure
- active pulmonary edema
- myocardial infarction or ischemia within the preceding 3 months
- renal insufficiency with CrCl \< 40 mL/minute
- CPT Class B or C cirrhosis and/or end-stage liver disease
- room air oxygen saturation \<90% or requirement of home O2
- hypernatremia with Na+ ≥ 150 mEq/L or Na+ \<130 mEq/L
- uncontrolled hypertension or hypotension
- pregnant status
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.