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

Sponsor

Do Hyun Park (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05832047

Collaborator

HK inno.N Corporation (Industry)

844

Enrollment

Locations

Arms

Anticipated Duration (Months)

281.3

Patients Per Site

46.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Disease	Drug: Hartmann Solution inno.N Drug: Plasma solution-A Inj.	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

844 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactated Ringer's solution	Drug: Hartmann Solution inno.N 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.
Active Comparator: Plasma solution	Drug: Plasma solution-A Inj. 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.

Arm

Intervention/Treatment

Experimental: Lactated Ringer's solution

Drug: Hartmann Solution inno.N

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.

Active Comparator: Plasma solution

Drug: Plasma solution-A Inj.

Outcome Measures

Primary Outcome Measures

Occurrence of pancreatitis after ERCP [24 hours [end of the study period] after ERCP]

Secondary Outcome Measures

Number of Participants with Clinical signs of fluid overload [4 and 24 hours [end of the study period] after ERCP]
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.
Number of Participants with hyperamylasemia [4 and 24 hours [end of the study period] after ERCP]
Occurrence or aggravation of abdominal pain [4 and 24 hours [end of the study period] after ERCP]
Days of stay (days from ERCP implementation date to) [Discharge date (approximately up to day 7)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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,

40 years old or younger
Oddi sphincter dysfunction
Normal bilirubinemia
History of recurrent pancreatitis
When infusion of contrast agent into the pancreatic duct is required
When endoscopic papillary incision or pancreatic ductal sphincterotomy is required
When a preliminary incision is required
If balloon dilation of the biliary sphincter is planned
If endoscopic papillary tumor resection is planned
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.

Those who have not consented to the study
Those under 18 years of age
Patients with severe comorbidities (end-stage kidney disease, end-stage chronic obstructive pulmonary disease, end-stage heart failure, hypoglycemic dysregulation, , , decompensated cirrhosis, )
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)
Patients with acute pancreatitis
Patients with chronic pancreatitis
Patients with heart failure (NYHA class 2 or higher)
Clinical signs of fluid overload
Hypernatremia (>150 mEq/L) or hyponatremia (<130mEq/L)
Patients who have undergone endoscopic papillary sphincterotomy
Patients who have undergone endoscopic papillary sphincter dilation
Patients with hypercalcemia or alkalemia
Patients scheduled for regular endoscopic biliary drainage tube replacement
Low-risk patients with pancreatic head tumors and predicted to have low pancreatitis
Patients who cannot access the nipple due to surgical deformity