Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis
STRIPE
1 other identifier
interventional
505
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2024
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2024
CompletedFirst Posted
Study publicly available on registry
February 15, 2024
CompletedStudy Start
First participant enrolled
November 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 29, 2026
April 1, 2026
3.6 years
February 7, 2024
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Serum amylase
24 hours
Secondary Outcomes (8)
Pancreatitis
7 days
Bleeding
30 days
Cholangitis
14 days
Cardiorespiratory adverse event
7 days
Serum lipase
24 hours
- +3 more secondary outcomes
Study Arms (5)
Ringer's lactate 2500 cc IV
EXPERIMENTALRinger's lactate 2000 cc IV
EXPERIMENTALRinger's lactate 1500 cc IV
EXPERIMENTALRinger's lactate 1000 cc IV
EXPERIMENTALRinger's lactate 500 cc IV
ACTIVE COMPARATORInterventions
Intravenous Ringer's lactate
Eligibility Criteria
You may qualify 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 may not qualify 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2024
First Posted
February 15, 2024
Study Start
November 22, 2024
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04