Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis
ConditionPost-ERCP Acute Pancreatitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Calgary
About this trial
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. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intravenous Ringer's lactate
Other interventionIntravenous Ringer's lactate
Treatment groups
505 Participants
are divided into 5 treatment groupsGroup A: Ringer's lactate 2500 cc IVExperimental treatment 1 intervention
Group B: Ringer's lactate 2000 cc IVExperimental treatment 1 intervention
Group C: Ringer's lactate 1500 cc IVExperimental treatment 1 intervention
Group D: Ringer's lactate 1000 cc IVExperimental treatment 1 intervention
Group E: Ringer's lactate 500 cc IVActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Serum amylase
Time frame
24 hoursSecondary outcomes
1
Pancreatitis
Abdominal pain characteristic of pancreatitis occurring after ERCP resulting in admission of (or prolongation of admission by) at least 2 nights, with one or more of: (1) amylase and/or lipase \> 3 times the upper limit of normal when measured at least the day after ERCP and/or (2) imaging findings characteristic of pancreatitis.
Time frame
7 days2
Bleeding
Hematemesis, melena, or hematochezia (other than blood on toilet paper) resulting in one or more of the following: (1) hemoglobin drop \> 2g and/or a need for transfusion, (2) a procedure performed for evaluation of suspected bleeding, and/or (3) emergency department visit and/or admission to hospital and/or prolongation of existing admission by at least one night.
Time frame
30 days3
Cholangitis
Presentation that includes all of the following: (1) temperature \< 36.0°C or \> 38.0°C or white blood cell count \< 4,000/L or \> 10,000/L and (2) increase in bilirubin, alkaline phosphatase, or transaminases compared to pre-procedure, or, if previously normal, a rise in any parameter to \> 1.5 times the upper limit of normal, and (3) emergency department visit and/or admission to hospital and/or prolongation of existing admission by at least one night.
Time frame
14 days4
Cardiorespiratory adverse event
Cardiorespiratory signs and/or symptoms related to a non-gastrointestinal organ system, or sedation- or drug-related reaction occurring during or after ERCP. The event must (1) result in an unplanned emergency department visit, hospital admission, or prolongation of existing admission by at least one night and/or (2) prevent completion of the planned procedure and/or (3) result in death.
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov