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

Examination of loading transfusion with lactated Ringer's solution to prevent post-ERCP pancreatitis: Randomized controlled trial - Post-ERCP pancreatitis prevention effect by lactated Ringer's solution infusion

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000040745

Enrollment

868

Registered

2020-06-15

Start date

2020-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary-pancreatic disease

Interventions

Begin the infusion at a maintenance infusion volume of 1.5 ml/kg/h (or 2000 ml/24 h) before the start of ERCP. Maintenance infusion should be extracellular fluid (lactated Ringer&#39

s solution) or maintenance fluid (No. 3 solution). Add 2 ml/kg/h:8h (or 1000 ml/8h) from the start of ERCP as load infusion. The content of the infusion solution should be extracellular fluid (lac

s solution). When pancreatitis is diagnosed, a large volume of infusion is required for the treatment of acute pancreatitis. The volume of infusion after 24 hours from ERCP (next day) will be determ

s solution) or maintenance fluid (No. 3 solution). The normal infusion group, which is the control group, does not perform load infusion. When pancreatitis is diagnosed, a large volume of infusi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients 20 years or older at the time of consent acquisition (2) Gender: Any (3) Patients who are clinically indicated for ERCP and perform ERCP (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 can obtain written informed consent for participation in this study, comply with the compliance requirements during this study, receive the medical examination prescribed in this study plan, and report symptoms etc.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Post-ERCP pancreatitis incidence	—

Countries

Japan

Contacts

Public ContactYusuke Kurita

Yokohama City University Department of Gastroenterology and Hepatology

kurita1023@gmail.com045-787-2640

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026