Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4, Canada
Location status: Recruiting
NCT Number: NCT06260878
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 4
Calgary, Alberta, T1Y 6J4, Canada
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous Ringer's lactate
Time frame: 24 hours
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours
Time frame: 24 hours
Time frame: 24 hours
Time frame: 24 hours
Contact information is provided by the study sponsor or research team.
University of Calgary
Other
Acronym: STRIPE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05252754
Post-ERCP Acute Pancreatitis
Baltimore, Maryland, United States
View Trial DetailsNCT07117318
Non-steroid Anti-inflammatory Drugs, Pancreatic Duct Stent Placement
Beijing, Beijing Municipality, China
View Trial DetailsNCT05267379
Post-ERCP Acute Pancreatitis
Nijmegen, Gelderland, Netherlands
View Trial DetailsNCT07173179
Post-ERCP Acute Pancreatitis
Düzce, Turkey (Türkiye)
View Trial Details