Post-ERCP Acute Pancreatitis
Conditions
Brief summary
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.
Interventions
OTHERIntravenous Ringer's lactate
Intravenous Ringer's lactate
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients \>75 years of age) 2. ability to give informed consent 3. native major papillary anatomy 4. ability and willingness to obtain bloodwork the day after ERCP
Exclusion criteria
1. prior ERCP with sphincterotomy and/or sphincteroplasty 2. confirmed or suspected cholangitis or sepsis 3. confirmed pancreatitis, hyperlipasemia, or hyperamylasemia within the preceding 7 days 4. NYHA Class II or greater heart failure 5. active pulmonary edema 6. myocardial infarction or ischemia within the preceding 3 months 7. renal insufficiency with CrCl \< 40 mL/minute 8. CPT Class B or C cirrhosis and/or end-stage liver disease 9. room air oxygen saturation \<90% or requirement of home O2 10. hypernatremia with Na+ ≥ 150 mEq/L or Na+ \<130 mEq/L 11. uncontrolled hypertension or hypotension 12. pregnant status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum amylase | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pancreatitis | 7 days | 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. |
| Bleeding | 30 days | 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. |
| Cholangitis | 14 days | 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. |
| Cardiorespiratory adverse event | 7 days | 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. |
| Serum lipase | 24 hours | — |
| Electrolytes | 24 hours | — |
| Creatinine | 24 hours | — |
| Brain natriuretic peptide | 24 hours | — |
Countries
Canada
Contacts
CONTACTNauzer Forbes, MD, MSc
Outcome results
None listed