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

Phase 4

Recruiting

• Conditions: Post-ERCP Acute Pancreatitis
• Interventions: Other: Intravenous Ringer's lactate

• Registration Number: NCT06260878
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Study Start: 2024-11-22
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 505

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer's lactate 1500 cc IV	Intravenous Ringer's lactate	-
Ringer's lactate 1000 cc IV	Intravenous Ringer's lactate	-
Ringer's lactate 2500 cc IV	Intravenous Ringer's lactate	-
Ringer's lactate 2000 cc IV	Intravenous Ringer's lactate	-
Ringer's lactate 500 cc IV	Intravenous Ringer's lactate	-

Primary Outcome Measures

Name	Time	Method
Serum amylase	24 hours

Secondary Outcome Measures

Name	Time	Method
Brain natriuretic peptide	24 hours
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
Creatinine	24 hours
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.
Electrolytes	24 hours

Trial Locations

Locations (1)

Peter Lougheed Centre; 🇨🇦 Calgary, Alberta, Canada