Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorUniversity of South Florida

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Lactated Ringer

    Drug

    This is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.

  • Normal Saline 0.9% Infusion Solution Bag

    Drug

    This is a Normal Saline solution infusion before, during, and after the ERCP procedure.

Treatment groups

242 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Post-ercp pancreatitis

The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed.

Time frame
24 hours

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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