Back to resultsAggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP (Endoscopic Retrograde Cholangiopancreatography) Pancreatitis
Primary Purpose
Pancreatic Disease
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hartmann Solution inno.N
Plasma solution-A Inj.
Sponsored by
About this trial
This is an interventional prevention trial for Pancreatic Disease focused on measuring ERCP, Endoscopic retrograde cholangiopancreatography, Pancreatitis
Eligibility 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, 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
Sites / Locations
- Asan Medical CenterRecruiting
- Samsung Seoul HopitalRecruiting
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lactated Ringer's solution
Plasma solution
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of pancreatitis after ERCP
Secondary Outcome Measures
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.
Number of Participants with hyperamylasemia
Occurrence or aggravation of abdominal pain
Days of stay (days from ERCP implementation date to)
Full Information
NCT ID
NCT05832047
First Posted
April 3, 2023
Last Updated
July 13, 2023
Sponsor
Do Hyun Park
Collaborators
HK inno.N Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05832047
Brief Title
Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP (Endoscopic Retrograde Cholangiopancreatography) Pancreatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Do Hyun Park
Collaborators
HK inno.N Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Disease
Keywords
ERCP, Endoscopic retrograde cholangiopancreatography, Pancreatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
844 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lactated Ringer's solution
Arm Type
Experimental
Arm Title
Plasma solution
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hartmann Solution inno.N
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Plasma solution-A Inj.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of pancreatitis after ERCP
Time Frame
24 hours [end of the study period] after ERCP
Secondary Outcome Measure Information:
Title
Number of Participants with Clinical signs of fluid overload
Description
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.
Time Frame
4 and 24 hours [end of the study period] after ERCP
Title
Number of Participants with hyperamylasemia
Time Frame
4 and 24 hours [end of the study period] after ERCP
Title
Occurrence or aggravation of abdominal pain
Time Frame
4 and 24 hours [end of the study period] after ERCP
Title
Days of stay (days from ERCP implementation date to)
Time Frame
Discharge date (approximately up to day 7)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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,
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Ha Kim
Phone
82 2 3010 5739
Email
sp98rn@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Youngrang Lee
Phone
82 70 4469 3411
Email
ylee@alllivec.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do Hyun Park, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
82 2 3010 5739
First Name & Middle Initial & Last Name & Degree
Do Hyun Park, MD, PhD
Facility Name
Samsung Seoul Hopital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
82 2 3410 2980
First Name & Middle Initial & Last Name & Degree
Joo Kyung Park, MD, PhD
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
82 2 2072 0368
First Name & Middle Initial & Last Name & Degree
Woo Hyun Paik, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP (Endoscopic Retrograde Cholangiopancreatography) Pancreatitis
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