Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis

Phase 4RecruitingNCT06260878

University of Calgary505 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

505

Conditions

Post-ERCP Acute Pancreatitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Serum amylase

Time frame: 24 hours

Secondary Outcomes

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 days

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 days

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 days

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 days

Serum lipase

Time frame: 24 hours

Electrolytes

Time frame: 24 hours

Creatinine

Time frame: 24 hours

Brain natriuretic peptide

Time frame: 24 hours

Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts