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

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Do Hyun Park
• Collaborator: HK inno.N Corporation
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

Intact major papilla in patients with preserved papilla due to non-ERCP Enroll patients who agree to clinical trials if they are at average ~ high risk of pancreatitis (if one or more of the following items applies) after endoscopic retrograde cholangiopancreatography,

1. 40 years old or younger

2. Oddi sphincter dysfunction

3. Normal bilirubinemia

4. History of recurrent pancreatitis

5. When infusion of contrast agent into the pancreatic duct is required

6. When endoscopic papillary incision or pancreatic ductal sphincterotomy is required

7. When a preliminary incision is required

8. If balloon dilation of the biliary sphincter is planned

9. If endoscopic papillary tumor resection is planned

10. If participants have a periampullary tumor and plan to insert a self-expanding metal stent that is thought to be at a high risk of pancreatitis

Exclusion Criteria: Exclude any of the following items if applicable.

1. Those who have not consented to the study

2. Those under 18 years of age

3. Patients with severe comorbidities (end-stage kidney disease, end-stage chronic obstructive pulmonary disease, end-stage heart failure, hypoglycemic dysregulation, , , decompensated cirrhosis, )

4. Sepsis (if two or more of the following items apply):

• Temperature >38.3 or <36ºC

• Heart rate >90 beats/min

• Tachypnea, respiratory rate > 20 breaths/min

• Leukocytosis(WBC>12,000 µL^-1) or Leukopenia(WBC<4000 µL^-1)

5. Patients with acute pancreatitis

6. Patients with chronic pancreatitis

7. Patients with heart failure (NYHA class 2 or higher)

8. Clinical signs of fluid overload

9. Hypernatremia (>150 mEq/L) or hyponatremia (<130mEq/L)

10. Patients who have undergone endoscopic papillary sphincterotomy

11. Patients who have undergone endoscopic papillary sphincter dilation

12. Patients with hypercalcemia or alkalemia

13. Patients scheduled for regular endoscopic biliary drainage tube replacement

14. Low-risk patients with pancreatic head tumors and predicted to have low pancreatitis

15. Patients who cannot access the nipple due to surgical deformity