Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP Pancreatitis

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.

In real practice, it is crucial to consider not just the type of fluid utilized, but also the most effective fluid volume for preventing PEP, along with the optimal timing for administering the fluid. Given that a significant number of ERCPs are performed in outpatient settings in the USA and other countries, the current protocol allowing outpatients to occupy recovery areas for extended periods, such as 8 hours post-ERCP, seems challenging to implement in real clinical practice. These considerations highlight the necessity for a re-evaluation of existing guidelines. Therefore, the present reassessment aims, not only to optimize efficiency and patient flow in medical settings but also to evaluate the effectiveness of the protocol in preventing PEP considering practical duration of intravenous fluid infusion, such as 4 hours postprocedure.

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 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 pancreatitis
• Lack of access to the major duodenal papilla due to surgically altered anatomy