About this trial
This is a randomized, double-blinded, controlled trial. This study is a head to head comparison of normal saline (NS) infusion versus Lactated Ringer's (LR) infusion in patients, with the primary outcome of post-ERCP pancreatitis occurrence. Patients will be randomized to either the NS infusion group or the LR infusion group. IVF will be started pre-procedurally and will be continued throughout the procedure. A IVF bolus will be given at the end of the procedure and then continued as a continuous infusion. Our null hypothesis is that there will be no significant difference in the rate of occurrence of post-ERCP pancreatitis between the infusion of LR and NS solutions. Our alternative hypothesis is that patients receiving LR solution infusion will experience a decreased rate of post-ERCP pancreatitis compared to patients receiving NS solution infusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suspicion of Oddi dysfunction
Personal history of post-ERCP pancreatitis
More than 8 cannulation attempts
Precut sphincterotomy
Disqualifiers
Patients aged less than 18
Inability to provide informed consent
Pregnancy
Active acute pancreatitis
Trial design
Parallel
Treatments tested in this trial
Lactated Ringer
DrugThis is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.
Normal Saline 0.9% Infusion Solution Bag
DrugThis is a Normal Saline solution infusion before, during, and after the ERCP procedure.
Treatment groups
Trial outcomes
Primary outcomes
Post-ercp pancreatitis
The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed.
Locations
Sponsors and contacts
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