High Volume Lactated Ringer's Solution and Pancreatitis

Study Overview
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Brief Summary
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The purpose of this study is to examine whether giving large amounts of intravenous (IV) fluids will reduce the risk of developing a complication known as post-ERCP pancreatitis (PEP). Pancreatitis is inflammation of the pancreas, and it is the most frequent serious complication of ERCP. Typically, a small amount of IV fluids are given during this procedure (  1 liter). We are testing whether using a larger amount of fluids (2 - 3 liters) will reduce the risk of PEP.

Detailed Description
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This trial is designed as a phase II/III study. The phase II portion of the trial will be completed to establish safety and efficacy data prior to proceeding with a phase III study. The phase II trial will enroll 110 patients that are undergoing elective ERCP as outpatients. Following the phase II portion, if the data suggests that the intervention arm (high volume group) is safe, the investigators will begin enrolling patients who are undergoing ERCP in a more urgent setting as inpatients. We plan on enrolling 1,400 consecutive high risk patients undergoing ERCP. We are assuming a baseline PEP risk of 9.2%. Fluid administration will be based on Ideal Body Weight (IBW) in order to standardize the aggressive fluid administration across all body weights and reduce the potential for adverse cardiopulmonary outcomes. All participants will be monitored for 90 minutes following their procedure to assess the development of any adverse symptoms. Analysis by a data safety monitoring board (DSMB) will take place throughout the study. The DSMB is comprised of a panel of experts independent of NorthShore University HealthSystem.

Official Title
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Perioperative Intravenous Administration of High Volume Lactated Ringer's Solution and the Risk of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Conditions
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Pancreatitis

Intervention / Treatment
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* Other: Administration of Lactated Ringer's (LR) Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients to be included in the study are those undergoing ERCP with the following: Clinical suspicion of sphincter of Oddi dysfunction History of post-ERCP pancreatitis (at least one episode) Pancreatic sphincterotomy Pre-cut (access) sphincterotomy Ampullectomy Exclusion Criteria: Age < 18 years old Intrauterine pregnancy or breastfeeding mother Congestive heart failure Advanced/symptomatic coronary artery disease Known ascites Renal failure Active or recent gastrointestinal hemorrhage Acute pancreatitis within 72 hours prior to ERCP

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Volume Group (Intervention Arm)<br>Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen: initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour LR fluid infusion during the procedure at 5 cc/kg/hr Post-procedure bolus of 20 cc/kg over 90 minutes | Other: Administration of Lactated Ringer's (LR) Solution<br>* Patients will be randomized to low volume or high volume group. Patient in the low volume group will receive fluids via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period. Patients in the high volume group will receive fluids via infusion by the following weight based regimen: initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour LR fluid infusion during the procedure at 5 cc/kg/hr Post-procedure bolus of 20 cc/kg over 90 minutes<br>|
| Active Comparator: Low Volume Group (Control Arm)<br>Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period. | Other: Administration of Lactated Ringer's (LR) Solution<br>* Patients will be randomized to low volume or high volume group. Patient in the low volume group will receive fluids via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period. Patients in the high volume group will receive fluids via infusion by the following weight based regimen: initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour LR fluid infusion during the procedure at 5 cc/kg/hr Post-procedure bolus of 20 cc/kg over 90 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Post-ERCP Pancreatitis | Patients will be monitored after procedure to see if they develop abdominal pain. If so, serum amylase and lipase blood draws will be completed at least once every 24 hours following procedure to monitor the development of post-ERCP pancreatitis. If patients do not develop abdominal pain following the procedure, research staff will follow up with the patients 5 days and 29 days after the procedure to evaluate for the development of post-ERCP pancreatitis and other related or unrelated complications. | Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events Related to Fluid Overload | A portion of the study will assess whether there is a significant risk of adverse events related to fluid overload states in the high volume (HV) intervention arm. We anticipate the rate of adverse events in patients randomized to the HV arm to be small. By using more modest, weight based regimens, we aim to optimize benefit while eliminating overly aggressive fluid administration and causing undue harm. | Phase II portion ( 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatitis, Endoscopic retrograde cholangiopancreatography, Cholangiopancreatography, Endoscopic Retrograde, ERCP, High Volume, Lactated Ringer, Intravenous Administration, Sphincterotomy, Endoscopic, Pancreas