Examination of loading transfusion to prevent post-ERCP pancreatitis: Randomized controlled trial

Not Applicable

• Conditions: Biliary-pancreatic disease

• Registration Number: JPRN-UMIN000040745
• Lead Sponsor: Yokohama City University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-15
• Last Update Posted: 17 October 2023
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 868

Inclusion Criteria

Not provided

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 the combination therapy and medical findings.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-ERCP pancreatitis incidence