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

NCT05832047 | Completed Phase 4

• 1 other identifier: DHP_ALPS study
• Study Type: interventional
• Target: 844
• Locations: 1 country
• Sites: 3

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. In previous comparative studies related to PEP prevention, research bias may have been introduced because of insufficient blinding of the treatment strategies, as well as instances where the evaluating investigator did not perform blinding. We are therefore conducting a multicenter, randomized comparative study double-blinded as to the two types of fluid (lactated Ringer's solution or plasma solution), and in which the endoscopists, outcome assessors and patients are blinded to the randomization allocation.

Conditions

Pancreatic Disease

Keywords

ERCP; Endoscopic retrograde cholangiopancreatography; Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Occurrence of pancreatitis after ERCP

  The new onset or worsening of pain in the upper abdomen, accompanied by an elevation of pancreatic enzymes to at least three times the upper normal level within 24 hours after the procedure, requiring hospitalization for a minimum of two nights.

  the next morning or within 24 hours after ERCP

Secondary Outcomes (5)

• Occurrence of pancreatitis after ERCP at 4 hours after ERCP

  4 hours after ERCP

• Number of Participants with Clinical signs of fluid overload

  4 hours and, and the next morning or within 24 hours after ERCP

• Number of Participants with Asymptomatic Hyperamylasemia

  4 hours and, the next morning or within 24 hours after ERCP

• Occurrence or aggravation of upper abdominal pain

  4 hours and, the next morning or within 24 hours after ERCP

• Days of ERCP-related hospital stay

  Time for upper abdominal pain to disappear after the date of ERCP - up to 20 days

Study Arms (2)

Plasma solution

EXPERIMENTAL

Plasma solution (HK inno.N Corp., Seoul, Republic of Korea) is a balanced crystalloid solution that contains the same ingredients as Plasma-Lyte A (Baxter International, Deer field, Ill) . Preprocedure hydration begins 30-90 min before ERCP with an infusion rate of 10 mL/kg. All the ERCP procedures are performed under sedation with balanced propofol sedation (incremental dose of propofol in combination with fixed doses of fentanyl and midazolam), without general anaesthesia. The infusion rate during ERCP and 30-60 min after ERCP is 3 mL/kg/hour and 10 mL/kg, respectively (in the case of a 10 mL/kg injection after the procedure, the injection should be stopped at the point where it is necessary to move from the endoscopy room to the ward after the procedure, and the injection rate can be changed to 3 mL/kg/hour).

Drug: Plasma solution (4-hour aggressive hydration); Drug: 8-hour aggressive hydration

Lactated Ringer's solution

ACTIVE COMPARATOR

Preprocedure hydration begins 30-90 min before ERCP with an infusion rate of 10 mL/kg. All the ERCP procedures are performed under sedation with balanced propofol sedation (incremental dose of propofol in combination with fixed doses of fentanyl and midazolam), without general anaesthesia. The infusion rate during ERCP and 30-60 min after ERCP is 3 mL/kg/hour and 10 mL/kg, respectively (in the case of a 10 mL/kg injection after the procedure, the injection should be stopped at the point where it is necessary to move from the endoscopy room to the ward after the procedure, and the injection rate can be changed to 3 mL/kg/hour).

Drug: Lactated Ringer solution (4-hour aggressive hydration); Drug: 8-hour aggressive hydration

Interventions

Plasma solution (4-hour aggressive hydration) DRUG

Aggressive hydration : 10 mL/kg injection within 30\~90min 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.

Also known as: Plasma solution-A Inj.

Plasma solution

Lactated Ringer solution (4-hour aggressive hydration) DRUG

Aggressive hydration : 10 mL/kg injection within 30\~90min 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.

Also known as: Hartmann Solution inno.N

Lactated Ringer's solution

8-hour aggressive hydration DRUG

If patients experienced postprocedural abdominal pain Numerical Rating Scale (NRS score\>3) or a worsening of abdominal pain compared with the pain before ERCP, the administration of study fluid continues until 8 hours (3 mL/kg/hr ) regardless of the results of serum amylase/lipase within 4 hours after ERCP because serum amylase/lipase within 4 hours after ERCP may have a result approximately 1-2 hours (5 hours-6 hours after ERCP) after blood sampling

Also known as: 8-h AH

Lactated Ringer's solution; Plasma solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• Subjects are excluded if they meet any of the following items.
• Not consented to study participation
• 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

Sponsors & Collaborators

• Do Hyun Park: lead
• HK inno.N Corporation: collaborator

Study Sites (3)

Asan Medical Center

Seoul, South Korea

Location

Samsung Seoul Hopital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Cho IR, Choi JH, Park JK, Huh G, Lee SH, Paik WH, Park DH. Aggressive hydration with lactated Ringer's solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial. BMJ Open. 2024 Jul 1;14(7):e084052. doi: 10.1136/bmjopen-2024-084052.

  PMID: 38955368 DERIVED

MeSH Terms

Conditions

Pancreatic Diseases; Pancreatitis

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Do Hyun Park, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 27, 2023
• Study Start: June 19, 2023
• Primary Completion: July 25, 2024
• Study Completion: January 20, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)