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A Study to Evaluate the Safety and Effectiveness of Ringer's Solution Hydration for Preventing Pancreatitis After ERCP

Efficacy and Safety of Clinically Feasible Ringer's Solution-Based Aggressive Hydration for the Prevention of Post-ERCP Pancreatitis: A Multicenter Pilot Single-Arm Trial - RAPID-PEP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059983
Enrollment
120
Registered
2026-04-01
Start date
2026-03-01
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 disease

Interventions

Aggressive hydration: On the day of ERCP, administer lactated Ringer&#39
s solution or acetate Ringer&#39
s solution as a continuous infusion at 2.5 mL/kg/hr for 24 hours. Alternatively, administer a 24-hour continuous infusion of lactated or acetate Ringer&#39
s solution in the volume calculated according to the table below.

Sponsors

Kobe University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who require ERCP for diagnosis and/or treatment via a biliary approach (2) Patients with no history of endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilatation (EPBD) (3) Patients aged >18 and <85 years (4) Patients in whom there is sufficient time between obtaining consent and the start of ERCP to initiate the protocol treatment before ERCP (5) Patients who provide written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: (1) Patients who meet any of the following cardiac criteria: (i) New York Heart Association (NYHA) functional class II or higher (ii) Serum BNP > 100 pg/mL or serum NT-proBNP > 400 pg/mL (2) Patients with renal dysfunction (eGFR < 60 mL/min/1.73 m2) (3) Patients with respiratory failure (SpO2 < 90% on room air) (4) Patients who already have pancreatitis prior to ERCP (5) Patients who, before ERCP, require massive fluid infusion because of septic shock or similar conditions (6) Patients with hypernatremia (serum Na > 147 mEq/L) (7) Patients with physical findings suggesting fluid overload, such as peripheral edema or pulmonary edema (8) Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) >= 3 (9) Patients who require ERCP via a pancreatic duct approach for diagnostic or therapeutic purposes (10) Patients with surgically altered gastrointestinal anatomy other than Billroth I reconstruction (11) Patients in whom papillary access is impossible or expected to be impossible because of organic gastrointestinal stenosis or similar conditions (12) Pregnant women or women who may be pregnant (13) Patients whom the principal investigator or subinvestigator judges to be inappropriate for inclusion in this study

Design outcomes

Primary

MeasureTime frame
incidence of post-ERCP pancreatitis—

Countries

Japan

Contacts

Public ContactAkira Shirohata

Kobe University Hospital Division of Gastroenterology, Department of Internal Medicine

white229@med.kobe-u.ac.jp078-382-5111

Outcome results

None listed

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