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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Disease
• Intervention / Treatment: Drug: Hartmann Solution inno.N; Drug: Plasma solution-A Inj.

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 Type: Interventional
• Enrollment (Estimated): 844
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Eun Ha Kim; Phone Number: 82 2 3010 5739; Email: sp98rn@gmail.com
• Study Contact Backup: Name: SungJin Eum; Email: alpscra@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Principal Investigator: Do Hyun Park, MD, PhD
    • Contact: Phone Number: 82 2 3010 5739
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Phone Number: 82 2 2072 0368
    • Principal Investigator: Woo Hyun Paik, MD, PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Seoul Hopital
    • Contact: Phone Number: 82 2 3410 2980
    • Principal Investigator: Joo Kyung Park, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Do Hyun Park
• Collaborators: HK inno.N Corporation
• Investigators: Principal Investigator: Do Hyun Park, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: ERCP; Endoscopic retrograde cholangiopancreatography; Pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatitis; Pancreatic Diseases; Pharmaceutical Solutions
• Other Study ID Numbers: DHP_ALPS study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No