Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis (STRIPE)

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 Overview

• Status: Recruiting
• Conditions: Post-ERCP Acute Pancreatitis
• Intervention / Treatment: Other: Intravenous Ringer's lactate

• Study Type: Interventional
• Enrollment (Estimated): 505
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nauzer Forbes, MD, MSc; Phone Number: 403-880-8508; Email: nauzer.forbes@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T1Y 6J4
      • Recruiting
      • Peter Lougheed Centre
      • Contact: Nauzer Forbes, MD; Phone Number: 403-880-8508; Email: nauzer.forbes@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ringer's lactate 2500 cc IV	Other: Intravenous Ringer's lactate; Intravenous Ringer's lactate
Experimental: Ringer's lactate 2000 cc IV	Other: Intravenous Ringer's lactate; Intravenous Ringer's lactate
Experimental: Ringer's lactate 1500 cc IV	Other: Intravenous Ringer's lactate; Intravenous Ringer's lactate
Experimental: Ringer's lactate 1000 cc IV	Other: Intravenous Ringer's lactate; Intravenous Ringer's lactate
Active Comparator: Ringer's lactate 500 cc IV	Other: Intravenous Ringer's lactate; Intravenous Ringer's lactate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum amylase	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	7 days
Serum lipase		24 hours
Electrolytes		24 hours
Creatinine		24 hours
Brain natriuretic peptide		24 hours

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: REB23-0625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No