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

Post-ERCP Acute Pancreatitis Clinical Trial

— STRIPE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06260878
• Other study ID #: REB23-0625
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: February 2024
• Source: University of Calgary
• Contact: Nauzer Forbes, MD, MSc
• Phone: 403-880-8508
• Email: nauzer.forbes[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 505
• Est. completion date: June 30, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Other:
• Intravenous Ringer's lactate
Intravenous Ringer's lactate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum amylase		24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Serum lipase		24 hours
Secondary	Electrolytes		24 hours
Secondary	Creatinine		24 hours
Secondary	Brain natriuretic peptide		24 hours