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

Pancreatic Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05832047
• Other study ID #: DHP_ALPS study
• Status: Recruiting
• Phase: Phase 4
• Start date: June 19, 2023
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: Eun Ha Kim
• Phone: 82 2 3010 5739
• Email: sp98rn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 844
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Disease
• Pancreatic Diseases
• Pancreatitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Seoul Hopital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Do Hyun Park	HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of pancreatitis after ERCP		the next morning or within 24 hours [end of the study period] after ERCP
Secondary	Occurrence of pancreatitis after ERCP		4 hours after ERCP
Secondary	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
Secondary	Number of Participants with Hyperamylasemia		4 hours and, the next morning or within 24 hours [end of the study period] after ERCP
Secondary	Occurrence or aggravation of upper abdominal pain		4 hours and, the next morning or within 24 hours [end of the study period] after ERCP
Secondary	Days of ERCP-related hospital stay		Time for upper abdominal pain to disappear after the date of ERCP - up to 20 days