Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP (Endoscopic Retrograde Cholangiopancreatography) Pancreatitis

Study Overview
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Brief Summary
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In the existing Aggressive hydration comparison study related to the prevention of post-ERCP pancreatitis (PEP), research bias may occur due to the lack of blinding between fluids, so in this study, the investigators will conduct a multicenter randomized comparative study in which the comparative fluids are double-blinded to observe differences between fluids in the preventive effect of pancreatitis that occurs after ERCP (endoscopic retrograde cholangiopancreatography). A total of 844 patients scheduled for ERCP will be enrolled in this clinical trial and randomly assigned to the lactated Ringer's solution or to the Plasma solution in a 1:1 ratio. Eligible patients will receive study drug or control drug for up to 24 hours before and after ERCP implementation.

Detailed Description
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Post-ERCP pancreatitis (PEP), which occurs in 2% to 15% of all patients undergoing ERCP and is treated conservatively with fasting and sufficient fluid supply according to the standards of care for general acute pancreatitis, and most patients improve within a few days without major complications. However, high-risk patients are more susceptible to PEP with incidence rates between 15% and 42%, and severe pancreatitis can develop in 11.4% of PEP cases with a 3% mortality rate. Therefore, there are significant unmet needs for PEP patients. In this trial, all patients will receive aggressive hydration involving fluids that are commercially available and widely administered. The trial aims to minimize potential risks and has established routine safety monitoring to protect the participants.

Official Title
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Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP (Endoscopic Retrograde Cholangiopancreatography) Pancreatitis : Multicenter, Double Blind, Randomized Controlled Trial

Conditions
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Pancreatic Disease

Intervention / Treatment
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* Drug: Plasma solution-A Inj.
* Drug: Hartmann Solution inno.N


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Among patients with naive major duodenal papilla in patients, we will include those who are at average-to-high risk of PEP (if one or more of the following criteria) after ERCP and agree to enroll in this clinical trial. 40 years of age or younger (Suspected) Sphincter of oddi dysfunction The normal level of serum total bilirubin History of recurrent pancreatitis Require injection of a contrast agent into the pancreatic duct Require endoscopic biliary or pancreatic sphincterotomy Require precut sphincterotomy Require endoscopic papillary balloon dilation Planned endoscopic papillectomy Diagnosed with periampullary tumor and planned for insertion of a self-expanding metal stent Exclusion Criteria: Subjects are excluded if they meet any of the following items. Not consented to study participation 18 years of age or younger Severe comorbidities (e.g., end-stage kidney disease, end-stage chronic obstructive pulmonary disease, hypoglycemic dysregulation, decompensated liver cirrhosis) Sepsis (defined as meeting two or more of the following items): Body temperature >38.3ºC or <36ºC Heart rate >90 beats/min Tachypnea (respiratory rate > 20 breaths/min) Leukocytosis (WBC >12,000 /uL) or leukopenia (WBC <4000 /uL) Acute pancreatitis Chronic pancreatitis Heart failure (NYHA class 2 or higher) Clinical signs of fluid overload Hypernatremia (>150 mEq/L) or hyponatremia (<130 mEq/L) History of endoscopic sphincterotomy History of endoscopic papillary (balloon) dilation Hypercalcemia or alkalemia Scheduled for regular endoscopic biliary stent change Patients with pancreatic head tumors and a presumed low risk for PEP Lack of access to the major duodenal papilla due to surgically altered anatomy

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plasma solution<br> | Drug: Plasma solution-A Inj.<br>* Aggressive hydration : 10 mL/kg injection within 30 60min before procedure, 3 mL/kg/hr fluid injection during procedure, 10 mL/kg injection within 30 60min after procedure, fluid, injection at 3 mL/kg/hr for 4 hours (up to 24 hours) thereafter.<br>|
| Active Comparator: Lactated Ringer's solution<br> | Drug: Hartmann Solution inno.N<br>* Aggressive hydration : 10 mL/kg injection within 30 60min before procedure, 3 mL/kg/hr fluid injection during procedure, 10 mL/kg injection within 30 60min after procedure, fluid, injection at 3 mL/kg/hr for 4 hours (up to 24 hours) thereafter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of pancreatitis after ERCP |  | the next morning or within 24 hours [end of the study period] after ERCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of pancreatitis after ERCP |  | 4 hours after ERCP | 
| Number of Participants with Clinical signs of fluid overload | Clinical signs of fluid overload, for example, peripheral edema, pulmonary rales, increased jugular venous pressure, hepatojugular reflux, or both wll be monitored by investigator. If these signs are observed, hemodynamic testing or imaging studies will be done to investigate the evidence of pulmonary oedema, peripheral oedema, cardiac insufficiency and hypernatraemia. | 4 hours and, and the next morning or within 24 hours [end of the study period] after ERCP | 
| Number of Participants with Hyperamylasemia |  | 4 hours and, the next morning or within 24 hours [end of the study period] after ERCP | 
| Occurrence or aggravation of upper abdominal pain |  | 4 hours and, the next morning or within 24 hours [end of the study period] after ERCP | 
| Days of ERCP-related hospital stay |  | Time for upper abdominal pain to disappear after the date of ERCP - up to 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, Endoscopic retrograde cholangiopancreatography, Pancreatitis