Overview
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.
Description
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.
Eligibility
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.
1. 40 years of age or younger
2. (Suspected) Sphincter of oddi dysfunction
3. The normal level of serum total bilirubin
4. History of recurrent pancreatitis
5. Require injection of a contrast agent into the pancreatic duct
6. Require endoscopic biliary or pancreatic sphincterotomy
7. Require precut sphincterotomy
8. Require endoscopic papillary balloon dilation
9. Planned endoscopic papillectomy
10. 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.
1. Not consented to study participation
2. 18 years of age or younger
3. Severe comorbidities (e.g., end-stage kidney disease, end-stage chronic obstructive
pulmonary disease, hypoglycemic dysregulation, decompensated liver cirrhosis)
4. 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)
5. Acute pancreatitis
6. Chronic pancreatitis
7. Heart failure (NYHA class 2 or higher)
8. Clinical signs of fluid overload
9. Hypernatremia (>150 mEq/L) or hyponatremia (<130 mEq/L)
10. History of endoscopic sphincterotomy
11. History of endoscopic papillary (balloon) dilation
12. Hypercalcemia or alkalemia
13. Scheduled for regular endoscopic biliary stent change
14. Patients with pancreatic head tumors and a presumed low risk for PEP
15. Lack of access to the major duodenal papilla due to surgically altered anatomy