Examination of post-ERCP pancreatitis preventive effect of load infusion therapy with lactated Ringer's solutionRandomized controlled trial

Phase 2

Recruiting

• Conditions: Biliary-pancreatic diseases for which ERCP is indicated; Choledocholithiasis, acute cholangitis, acute cholecystitis, cholangiocarcinoma, primary sclerosing cholangitis, IgG4-related sclerosing cholangitis, pancreatic cancer, autoimmune pancreatitis, pancreatic duct stricture, cystic pancreatic tumor

• Registration Number: JPRN-jRCTs031200202
• Lead Sponsor: Kurita Yusuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 950

Inclusion Criteria

(1) Patients aged 20 to 85 at the time of consent acquisition
(2) Gender: Any
(3) Patients who are clinically indicated for ERCP and undergo ERCP (malignant biliary stricture, pancreatic cancer, acute cholangitis, common bile duct stone, IgG4 sclerosing cholangitis, primary sclerosing cholangitis, etc.)
(4) Post-ERCP pancreatitis risk (moderate or higher)
(5) PS is 2 or less
(6) Patients who can take oral drugs, meals and beverages
(7) Patients expected to have stable primary disease (including cancer) 6 months after registration during the observation period
(8) Patients who have written informed consent to participate in this study, who comply with the compliance items during this study participation, who can receive the medical examination prescribed in this study plan and report symptoms etc.

Exclusion Criteria

(1) Patients with low risk of post-ERCP pancreatitis (confirmed cases of chronic pancreatitis, pancreatic head tumor, periodic biliary stent replacement)
(2) Patients with acute pancreatitis
(3) Patients with hypotension including sepsis
(4) Heart failure patients (NYHA Class II or above)
(5) Patients with renal failure (creatinine clearance <30 mL/min)
(6) Patients with liver failure (patients with cirrhosis and ascites)
(7) Patients with respiratory failure (defined as oxygen saturation <90%)
(8) Hyponatremia (Na+ levels <130mEq/L)
(9) Hypernatremia (Na+ levels> 150mEq/L)
(10) Hypokalemia (K+ levels <3.0mEq/L)
(11) Patients who are pregnant or breastfeeding, patients who wish to become pregnant during the study period, patients who wish to become pregnant of a partner during the study period.
(12) In addition, patients who are judged to be unsuitable for study participation by the investigator or investigator based on combination therapy and medical findings.
(13) Patients in other clinical studies or clinical trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-ERCP pancreatitis incidence: efficacy endpoint<br>This study examines the post-ERCP pancreatitis preventive effect of fluid loading. Therefore, the primary evaluation item this time is the post-ERCP pancreatitis incidence rate as a direct evaluation item.<br><br>Diagnostic criteria for post-ERCP pancreatitis<br>(1) Newly developed upper abdominal pain<br>(2) Pancreatic enzymes (amylase and/or lipase) increased more than 3 times the institutional upper limit of normal<br>(3) (1) and (2) within 24 hours after ERCP<br>(4) Hospitalization extension of 2 nights or more<br>Post-ERCP pancreatitis if all of the above are met