Using intravenous fluids to prevent pancreatitis after ERCP procedures
Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis
This study tests if different types of intravenous fluids can help prevent pancreatitis in patients undergoing ERCP procedures.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 505 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT06260878 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of various short-term intravenous fluid regimens in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, a common and serious complication. The trial aims to provide data on the efficacy of these fluid treatments, which could significantly influence ERCP practices globally. By focusing on patients undergoing ERCP, the study seeks to address a critical gap in current medical knowledge regarding preventive measures for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 who are scheduled for an ERCP and can provide informed consent.
Not a fit: Patients with prior ERCP complications, active infections, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for post-ERCP pancreatitis, reducing patient morbidity and healthcare costs.
How similar studies have performed: While there is limited data on the effectiveness of short-term fluid regimens for this specific purpose, the study addresses a significant gap in existing literature, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Calgary, Alberta
- Peter Lougheed Centre — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Nauzer Forbes, MD, MSc
- Email: nauzer.forbes@ucalgary.ca
- Phone: 403-880-8508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.