Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of the Use of Lactated Ringer's Solution During ERCP on Rate of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Conditions
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Post-ERCP Acute Pancreatitis

Intervention / Treatment
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* Drug: Lactated Ringer
* Drug: Normal Saline 0.9% Infusion Solution Bag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i. Possession of one of the following criteria which places the patient at high risk for post-ERCP pancreatitis and/or if patient is to undergo a planned endoscopic intervention deemed at high risk: Suspicion of Oddi dysfunction Personal history of post-ERCP pancreatitis More than 8 cannulation attempts Precut sphincterotomy Endoscopic papillary balloon dilation of an intact sphincter Endoscopic pancreatic duct sphincterotomy Ampullectomy Total bilirubin < 1.0 ii. Or possession of two or more of the following minor criteria: Female sex Age under 50 years Personal history of recurrent acute pancreatitis Pancreatic duct injection leading to acinarization or over 3 pancreatic duct injections Pancreatic duct cytology acquisition Exclusion Criteria: Patients aged less than 18 Inability to provide informed consent Pregnancy Active acute pancreatitis Any contraindication to aggressive IVF hydration: evidence of clinical volume overload (peripheral or pulmonary edema), respiratory compromise (oxygen saturation < 90% on room air), chronic kidney disease (creatinine clearance < 40 mL/min), systolic congestive heart failure (ejection fraction < 45%), cirrhosis, and severe electrolyte disturbance with sodium <130 mEq/L or >150 mEq/L If patient does not undergo a planned high-risk intervention If patient does not possess complete criteria which places them at high risk for post-ERCP pancreatitis Patients with cholangitis Patients with chronic and/or active pancreatitis Patients with a true NSAID allergy Patients greater than or equal to 75 years old

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Drug: Normal Saline 0.9% Infusion Solution Bag<br>* This is a Normal Saline solution infusion before, during, and after the ERCP procedure.<br>|
| Experimental: Experimental<br> | Drug: Lactated Ringer<br>* This is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ercp pancreatitis | The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-ERCP Acute Pancreatitis, Normal Saline, Lactated Ringer's